Clearance Summary
LIFESYNE SYSTEMS received FDA 510(k) clearance under submission number K030795, sponsored by Gmp/Companies, 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 2003-08-05.
- Submission: K030795
- Applicant / Sponsor: Gmp/Companies, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2910
- Decision date: 2003-08-05
Classification & Regulation
This clearance is catalogued under FDA product code DRG and 21 CFR 870.2910, within the Cardiovascular review panel as a Class II device.