|
Device |
system, monitoring, perinatal |
Product Code | HGM |
Regulation Number |
884.2740
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ADVANCED INSTRUMENTATIONS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
AIRSTRIP TECHNOLOGIES, LP |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ALERTWATCH, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BISTOS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
BLOOM TECHNOLOGIES NV |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CERNER CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CIVNET COMMUNICATION LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CLINICAL COMPUTER SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DATEX OHMEDA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EDAN INSTRUMENTS INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EDAN INSTRUMENTS, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EDAN INSTRUMENTS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
FARUS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GE HEALTHCARE INTEGRATED IT SOLUTIONS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GUANGDONG BIOLIGHT MEDITECH CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GUANGDONG BIOLIGHT MEDITECH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HUNTLEIGH HEALTHCARE LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
HUNTLEIGH HEALTHCARE LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MCKESSON INFORMATION SOLUTIONS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDIANA CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MINDCHILD MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
OB TOOLS, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SENSE4BABY, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SUNRAY MEDICAL APPARATUS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WIPRO GE HEALTHCARE PRIVATE, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|