Clearance Summary
SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565 received FDA 510(k) clearance under submission number K994353, sponsored by Precision Dynamics Corp.. 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 2000-03-22.
- Submission: K994353
- Applicant / Sponsor: Precision Dynamics Corp.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2720
- Decision date: 2000-03-22
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.