Clearance Summary
CLINITRON RITE-HITE received FDA 510(k) clearance under submission number K964223, 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 1997-05-28.
- Submission: K964223
- Applicant / Sponsor: Hill-Rom, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5160
- Decision date: 1997-05-28
Classification & Regulation
This clearance is catalogued under FDA product code INX and 21 CFR 890.5160, within the Physical Medicine review panel as a Class II device.