MODEL 151 FETAL MONITOR

System, Monitoring, Perinatal

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES

The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies with the FDA for Model 151 Fetal Monitor.

Pre-market Notification Details

Device IDK932077
510k NumberK932077
Device Name:MODEL 151 FETAL MONITOR
ClassificationSystem, Monitoring, Perinatal
Applicant GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 61 BARNES PARK RD., NORTH Wallingford,  CT  06492
ContactBrian R Barry
CorrespondentBrian R Barry
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 61 BARNES PARK RD., NORTH Wallingford,  CT  06492
Product CodeHGM  
CFR Regulation Number884.2740 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-04-29
Decision Date1994-03-31

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.