Clearance Summary
CARE TEC PORTABLE LOW AIR LOSS THERAPY SYSTEM received FDA 510(k) clearance under submission number K970362, sponsored by Apex Metal, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1997-05-16.
- Submission: K970362
- Applicant / Sponsor: Apex Metal, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5550
- Decision date: 1997-05-16
Classification & Regulation
This clearance is catalogued under FDA product code FNM and 21 CFR 880.5550, within the General Hospital review panel as a Class II device.