510(k) K894992
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 23, 1990
- Date Received
- August 8, 1989
- 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