510(k) K903623
K903623 is an FDA 510(k) premarket notification submitted by Corometrics Medical Systems, Inc. for the device "MODEL600 UTERINE ACTIVITY MONITOR". The FDA issued a decision of Substantially Equivalent on November 7, 1990. The device falls under product code HFM (Monitor, Uterine Contraction, External (For Use In Clinic)), a Class II device regulated under 21 CFR 884.2720. Corometrics Medical Systems, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 7, 1990
- Date Received
- August 9, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Uterine Contraction, External (For Use In Clinic)
- Device Class
- Class II
- Regulation Number
- 884.2720
- Review Panel
- OB
- Submission Type