510(k) K955443
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 20, 1996
- Date Received
- November 28, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transducer, Pressure, Intrauterine
- Device Class
- Class II
- Regulation Number
- 884.2700
- Review Panel
- OB
- Submission Type