510(k) K813298
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 8, 1981
- Date Received
- November 23, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stethoscope, Fetal
- Device Class
- Class I
- Regulation Number
- 884.2900
- Review Panel
- OB
- Submission Type