510(k) K905536
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 21, 1992
- Date Received
- December 11, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Fetal Doppler Ultrasound
- Device Class
- Class II
- Regulation Number
- 884.2660
- Review Panel
- RA
- Submission Type