510(k) K904691
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 19, 1991
- Date Received
- October 16, 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