The following data is part of a premarket notification filed by Ocg Systems, Inc. with the FDA for Disco Uterine Contraction Transducer & Accessories.
Device ID | K954847 |
510k Number | K954847 |
Device Name: | DISCO UTERINE CONTRACTION TRANSDUCER & ACCESSORIES |
Classification | Monitor, Uterine Contraction, External (for Use In Clinic) |
Applicant | OCG SYSTEMS, INC. 215 PROSPECT AVE. Highland Park, IL 60035 |
Contact | Fredric I Orkin |
Correspondent | Fredric I Orkin OCG SYSTEMS, INC. 215 PROSPECT AVE. Highland Park, IL 60035 |
Product Code | HFM |
CFR Regulation Number | 884.2720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-10-23 |
Decision Date | 1996-05-22 |
Summary: | summary |