Clearance Summary
LEFF STETHOSCOPE FOR FETAL HEART received FDA 510(k) clearance under submission number K761338, sponsored by J. Sklar Mfg. Co., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 1977-01-12.
- Submission: K761338
- Applicant / Sponsor: J. Sklar Mfg. Co., Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.2900
- Decision date: 1977-01-12
Classification & Regulation
This clearance is catalogued under FDA product code HGN and 21 CFR 884.2900, within the Obstetrics/Gynecology review panel as a Class I device.