|
Device |
computer, diagnostic, pre-programmed, single-function |
Product Code | DXG |
Regulation Number |
870.1435
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
APPLIED PHYSIOLOGY PTY LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BOMED INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARDIOX CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CHEETAH MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DIRECTED SYSTEMS LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
EDWARDS LIFESCIENCES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
1. K100709 EV1000 PLATFORM MODEL: EV1000A, EV1000DB, EV1000M
|
2. K103094 VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT / OXIMETR ...
|
3. K131588 VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY ...
|
4. K131892 EV1000 CLINICAL PLATFORM
|
EDWARDS LIFESCIENCES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
1. K100709 EV1000 PLATFORM MODEL: EV1000A, EV1000DB, EV1000M
|
2. K103094 VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT / OXIMETR ...
|
3. K131588 VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY ...
|
4. K131892 EV1000 CLINICAL PLATFORM
|
EDWARDS LIFESCIENCES, LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
1. K100709 EV1000 PLATFORM MODEL: EV1000A, EV1000DB, EV1000M
|
2. K103094 VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT / OXIMETR ...
|
3. K131588 VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY ...
|
4. K131892 EV1000 CLINICAL PLATFORM
|
GE HEALTHCARE FINLAND OY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ICU MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LIDCO LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
LIDCO LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PULSION MEDICAL SYSTEMS AG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PULSION MEDICAL SYSTEMS SE |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
PULSION MEDICAL SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RETIA MEDICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TRANSONIC SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
|
|
|
|