MODEL600 UTERINE ACTIVITY MONITOR

Monitor, Uterine Contraction, External (for Use In Clinic)

COROMETRICS MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Corometrics Medical Systems, Inc. with the FDA for Model600 Uterine Activity Monitor.

Pre-market Notification Details

Device IDK903623
510k NumberK903623
Device Name:MODEL600 UTERINE ACTIVITY MONITOR
ClassificationMonitor, Uterine Contraction, External (for Use In Clinic)
Applicant COROMETRICS MEDICAL SYSTEMS, INC. 61 BARNES PARK RD. NORTH P.O. BOX 333 Wallingford,  CT  06492
ContactBrian R Barry
CorrespondentBrian R Barry
COROMETRICS MEDICAL SYSTEMS, INC. 61 BARNES PARK RD. NORTH P.O. BOX 333 Wallingford,  CT  06492
Product CodeHFM  
CFR Regulation Number884.2720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-08-09
Decision Date1990-11-07

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