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 |