Premarket Reviews |
Manufacturer | Decision |
3B MEDICAL, INC |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
3B MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
3B PRODUCTS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
3B PRODUCTS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
A PLUS MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
AEIOMED, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AIRWAY MANAGEMENT, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
APEX MEDICAL CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
9
|
BMC MEDICAL CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BMC MEDICAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BMC MEDICAL.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BREATHE TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARDINAL HEALTH 207, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CHILDRENS MEDICAL VENTURES LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CIRCADIANCE LLC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
CIRCADIANCE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CURATIVE MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
DESHUM MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DEVILBISS HEALTHCARE LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DEVILBISS HEALTHCARE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
FISHER & PAYKEL HEALTHCARE LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
FISHER & PAYKEL HEALTHCARE LTD |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
FISHER & PAYKEL HEALTHCARE LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
FISHER & PAYKEL HEALTHCARE, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
HSINER COMPANY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HUMAN DESIGN MEDICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INNOMED TECHNOLOGIES INC./RESPCARE INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INSLEEP TECHNOLOGIES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INTERSURGICAL INCORPORATED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LAKEVIEW SLEEP CENTER |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PUR-SLEEP, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RESMED CORP |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
RESMED CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
RESMED LTD |
|
SUBSTANTIALLY EQUIVALENT
|
9
|
1. K082605 VPAP AUTO WITH HUMIDAIRE 3I
|
2. K082979 S8 ADVANCE
|
3. K082983 RESSCAN-PRO
|
4. K083816 RES TRAXX ONLINE, MODEL: R14
|
5. K090244 SWIFT FX
|
6. K091129 QUATTRO LT
|
7. K091947 S8 ASPEN WITH H4I PLUS
|
8. K092026 EASYCARE TX, TX LINK
|
9. K093684 EASYCARE ONLINE
|
10. K100772 MIRAGE MICRO MODEL 16333 (S), 16334 (M&L), 16335 ( ...
|
11. K102224 PIXI PEDIATRIC MASK
|
12. K102513 S9 VPAP ST WITH H5I
|
13. K102586 S9 VPAP ADAPT WITH H5I
|
14. K102746 MIRAGE FX
|
15. K110444 MIRAGE MICRO
|
16. K112393 TASMAN
|
17. K112489 SWIFT FX BELLA
|
18. K113127 MIRAGE QUATTRO
|
19. K113780 EASYCARE TX SYSTEM (CONNEXUNS)
|
20. K121705 GEO
|
21. K123789 SWIFT FX NANO
|
22. K123979 QUATTRO AIR
|
23. K132013 SWIFT AIR
|
24. K132606 S9 CRONULLA FOR HER
|
25. K132887 AIRFIT N10
|
26. K132901 AIRSOFT F15
|
27. K140159 S9 WANDA VPAP ST
|
28. K140279 S9 GREENHILLS
|
29. K143603 Darlinghurst Vented, Darlinghurst NV-AAV
|
30. K153563 AirFit F20
|
RESMED LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
30
|
1. K082605 VPAP AUTO WITH HUMIDAIRE 3I
|
2. K082979 S8 ADVANCE
|
3. K082983 RESSCAN-PRO
|
4. K083816 RES TRAXX ONLINE, MODEL: R14
|
5. K090244 SWIFT FX
|
6. K091129 QUATTRO LT
|
7. K091947 S8 ASPEN WITH H4I PLUS
|
8. K092026 EASYCARE TX, TX LINK
|
9. K093684 EASYCARE ONLINE
|
10. K100772 MIRAGE MICRO MODEL 16333 (S), 16334 (M&L), 16335 ( ...
|
11. K102224 PIXI PEDIATRIC MASK
|
12. K102513 S9 VPAP ST WITH H5I
|
13. K102586 S9 VPAP ADAPT WITH H5I
|
14. K102746 MIRAGE FX
|
15. K110444 MIRAGE MICRO
|
16. K112393 TASMAN
|
17. K112489 SWIFT FX BELLA
|
18. K113127 MIRAGE QUATTRO
|
19. K113780 EASYCARE TX SYSTEM (CONNEXUNS)
|
20. K121705 GEO
|
21. K123789 SWIFT FX NANO
|
22. K123979 QUATTRO AIR
|
23. K132013 SWIFT AIR
|
24. K132606 S9 CRONULLA FOR HER
|
25. K132887 AIRFIT N10
|
26. K132901 AIRSOFT F15
|
27. K140159 S9 WANDA VPAP ST
|
28. K140279 S9 GREENHILLS
|
29. K143603 Darlinghurst Vented, Darlinghurst NV-AAV
|
30. K153563 AirFit F20
|
RESMED PTY LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RESMED PTY LTD (REGISTRATION NUMBER: 3004604967) |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
RESPIRONICS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
RESPIRONICS INC. (DBA PHILIPS RESPIRONICS) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
RESPIRONICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
22
|
SALTER LABS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SEATTLE CHILDRENS HOSPITAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SKY WISE MEDICAL INSTRUMENT (SHEN ZHEN) CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SLEEPNET CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
8
|
SNAPCPAP |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SOMNETICS INTERNATIONAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
STEVENSON INDUSTRIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SUNRISE MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SUZHOU YUYUE MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SYSMED (CHINA) CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VEGA TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WEINMANN GERATE FUR MEDIZIN GMBH + CO. KG |
|
SUBSTANTIALLY EQUIVALENT
|
3
|