|
Device |
cable, transducer and electrode, patient, (including connector) |
Product Code | DSA |
Regulation Number |
870.2900
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
APK TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ATRILITY MEDICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AUTHENTIC MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BOSTON SCIENTIFIC CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CAREFUSION 2200 INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CAREFUSION 303, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CURBELL MEDICAL PRODUCTS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ENERGETIC DESIGNS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INTEGRAL PROCESS SAS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JKH USA, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDLINE INDUSTRIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDTRONIC , INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ORANTECH INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
QT MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN CHANGKE CONNECT ELECTRONICS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SHENZHEN CORERAY TECHNOLOGY., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
VOLCANO CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VYAIRE MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
XINKANG MEDICAL INSTRUMENT CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|