Clearance Summary
DYNAMICAIRE(TM) SLEEP SURFACE, ZONEAIR(TM) SLEEP SURFACE received FDA 510(k) clearance under submission number K945729, sponsored by Hill-Rom, 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 1995-02-27.
- Submission: K945729
- Applicant / Sponsor: Hill-Rom, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5170
- Decision date: 1995-02-27
Classification & Regulation
This clearance is catalogued under FDA product code IOQ and 21 CFR 890.5170, within the Physical Medicine review panel as a Class II device.