The following data is part of a premarket notification filed by Corometrics Medical Systems, Inc. with the FDA for Model600 Uterine Activity Monitor.
Device ID | K903623 |
510k Number | K903623 |
Device Name: | MODEL600 UTERINE ACTIVITY MONITOR |
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 | 1990-08-09 |
Decision Date | 1990-11-07 |