Clearance Summary
TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING received FDA 510(k) clearance under submission number K992811, sponsored by Epic Medical Equipment Services, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2000-01-18.
- Submission: K992811
- Applicant / Sponsor: Epic Medical Equipment Services, Inc.
- Clearance pathway: Abbreviated
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2720
- Decision date: 2000-01-18
Classification & Regulation
This clearance is catalogued under FDA product code HFM and 21 CFR 884.2720, within the Obstetrics/Gynecology review panel as a Class II device.