Clearance Summary
WALKCARE P200 SYSTEM received FDA 510(k) clearance under submission number K973592, sponsored by A.Stein - Regulatory Affairs Consulting. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1999-05-20.
- Submission: K973592
- Applicant / Sponsor: A.Stein - Regulatory Affairs Consulting
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5800
- Decision date: 1999-05-20
Classification & Regulation
This clearance is catalogued under FDA product code JOW and 21 CFR 870.5800, within the Cardiovascular review panel as a Class II device.