Clearance Summary
PROCEDURAL STRECHER WITH INTELLIDRIVE P8000 received FDA 510(k) clearance under submission number K112502, sponsored by Hill-Rom Co.. 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 2011-09-19.
- Submission: K112502
- Applicant / Sponsor: Hill-Rom Co.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3690
- Decision date: 2011-09-19
Classification & Regulation
This clearance is catalogued under FDA product code INK and 21 CFR 890.3690, within the Physical Medicine review panel as a Class II device.