510(k) K761338
K761338 is an FDA 510(k) premarket notification submitted by J. Sklar Mfg. Co., Inc. for the device "LEFF STETHOSCOPE FOR FETAL HEART". The FDA issued a decision of Substantially Equivalent on January 12, 1977. The device falls under product code HGN (Stethoscope, Fetal), a Class I device regulated under 21 CFR 884.2900. J. Sklar Mfg. Co., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 12, 1977
- Date Received
- December 27, 1976
- 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