Clearance Summary
PRESSUREGUARD IV received FDA 510(k) clearance under submission number K972486, sponsored by Span-America Medical Systems, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 1998-02-20.
- Submission: K972486
- Applicant / Sponsor: Span-America Medical Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5225
- Decision date: 1998-02-20
Classification & Regulation
This clearance is catalogued under FDA product code IKZ and 21 CFR 890.5225, within the Physical Medicine review panel as a Class II device.