DISCO UTERINE CONTRACTION TRANSDUCER & ACCESSORIES

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

OCG SYSTEMS, INC.

The following data is part of a premarket notification filed by Ocg Systems, Inc. with the FDA for Disco Uterine Contraction Transducer & Accessories.

Pre-market Notification Details

Device IDK954847
510k NumberK954847
Device Name:DISCO UTERINE CONTRACTION TRANSDUCER & ACCESSORIES
ClassificationMonitor, Uterine Contraction, External (for Use In Clinic)
Applicant OCG SYSTEMS, INC. 215 PROSPECT AVE. Highland Park,  IL  60035
ContactFredric I Orkin
CorrespondentFredric I Orkin
OCG SYSTEMS, INC. 215 PROSPECT AVE. Highland Park,  IL  60035
Product CodeHFM  
CFR Regulation Number884.2720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-10-23
Decision Date1996-05-22
Summary:summary

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