|
Device |
ventilator, non-continuous (respirator) |
Product Code | BZD |
Regulation Number |
868.5905
|
Device Class |
2
|
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
|
1. K083656 APEX MEDICAL XT AUTO CPAP 9S-005200
|
2. K103174 APEX MEDICAL WIZARD SERIES CPAP MASK
|
3. K112079 APEX MEDICAL XT AUTO CPAP WITH COMPLIANCE IMPROVEM ...
|
4. K120035 APEX MEDICAL ICH CPAP SERIES (9S-007XXX)
|
5. K121642 WIZARD 230 NASAL PILOW MASK
|
6. K141522 APEX MEDICAL CORP. ICH CPAP WITH PVA 9S-007XXX SER ...
|
7. K150111 Apex Medical Corp. iCH CPAP with PVA 9S-007XXX Ser ...
|
8. K182394 WiZARD 310/320 Series CPAP Mask
|
9. K193206 WiZARD 510 Nasal Mask
|
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
|
RESMED LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
30
|
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
|
|
|
|
|