Clearance Summary
PRECISION ONE LIFECARE; DETECTO; DETECTO received FDA 510(k) clearance under submission number K130952, sponsored by Precision One Lifecare, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2013-09-26.
- Submission: K130952
- Applicant / Sponsor: Precision One Lifecare, Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2770
- Decision date: 2013-09-26
Classification & Regulation
This clearance is catalogued under FDA product code MNW and 21 CFR 870.2770, within the Cardiovascular review panel as a Class II device.