Clearance Summary
SILKAIR LOW AIRLOSS THERAPY received FDA 510(k) clearance under submission number K964873, 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 1997-07-03.
- Submission: K964873
- Applicant / Sponsor: Hill-Rom, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5170
- Decision date: 1997-07-03
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.