The following data is part of a premarket notification filed by Corometrics Medical Systems, Inc. with the FDA for Catalog #2270aax, 2270dax Beltless Tocotransducer.
| Device ID | K891997 |
| 510k Number | K891997 |
| Device Name: | CATALOG #2270AAX, 2270DAX BELTLESS TOCOTRANSDUCER |
| Classification | Monitor, Uterine Contraction, External (for Use In Clinic) |
| Applicant | COROMETRICS MEDICAL SYSTEMS, INC. 61 BARNES PARK RD. NORTH P.O. BOX 333 Wallingford, CT 06492 |
| Contact | Brian R Barry |
| Correspondent | Brian R Barry COROMETRICS MEDICAL SYSTEMS, INC. 61 BARNES PARK RD. NORTH P.O. BOX 333 Wallingford, CT 06492 |
| Product Code | HFM |
| CFR Regulation Number | 884.2720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-28 |
| Decision Date | 1989-06-08 |