Clearance Summary
HILL-ROM PATIENT ENVIRONMENTAL CONTROL SYSTEM received FDA 510(k) clearance under submission number K921528, 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 1992-04-20.
- Submission: K921528
- Applicant / Sponsor: Hill-Rom, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3725
- Decision date: 1992-04-20
Classification & Regulation
This clearance is catalogued under FDA product code IQA and 21 CFR 890.3725, within the Physical Medicine review panel as a Class II device.