Clearance Summary
RHYTHM OF LIFE, MODEL R0901-05 received FDA 510(k) clearance under submission number K092408, sponsored by Rapid Response Solutions, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2009-10-14.
- Submission: K092408
- Applicant / Sponsor: Rapid Response Solutions, LLC
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5210
- Decision date: 2009-10-14
Classification & Regulation
This clearance is catalogued under FDA product code LIX and 21 CFR 870.5210, within the Cardiovascular review panel as a Class II device.