Clearance Summary
FETAL SPIRAL ELECTRODE, MODEL FSE07000 received FDA 510(k) clearance under submission number K030691, 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 2003-09-17.
- Submission: K030691
- Applicant / Sponsor: Clinical Innovations, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2675
- Decision date: 2003-09-17
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.