Clearance Summary
LIFE+CEL BATTERY received FDA 510(k) clearance under submission number K071164, sponsored by Amco International Manufacturing & Design, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2007-12-07.
- Submission: K071164
- Applicant / Sponsor: Amco International Manufacturing & Design, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1025
- Decision date: 2007-12-07
Classification & Regulation
This clearance is catalogued under FDA product code MHX and 21 CFR 870.1025, within the Cardiovascular review panel as a Class II device.