Clearance Summary
SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000 received FDA 510(k) clearance under submission number K003458, sponsored by Clinical Innovations, 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 2001-05-03.
- Submission: K003458
- Applicant / Sponsor: Clinical Innovations, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2675
- Decision date: 2001-05-03
Classification & Regulation
This clearance is catalogued under FDA product code HGP and 21 CFR 884.2675, within the Obstetrics/Gynecology review panel as a Class II device.