Clearance Summary
LIFESYNC ADAPTER, MODEL LS-302 received FDA 510(k) clearance under submission number K071751, sponsored by Lifesync Corporation. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2007-08-27.
- Submission: K071751
- Applicant / Sponsor: Lifesync Corporation
- Clearance pathway: Abbreviated
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2900
- Decision date: 2007-08-27
Classification & Regulation
This clearance is catalogued under FDA product code DSA and 21 CFR 870.2900, within the Cardiovascular review panel as a Class II device.