Clearance Summary
PRESSUREGUARD IV received FDA 510(k) clearance under submission number K951112, sponsored by Span-America Medical Systems, 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 1995-06-06.
- Submission: K951112
- Applicant / Sponsor: Span-America Medical Systems, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5550
- Decision date: 1995-06-06
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.