Clearance Summary
Hill-Rom Wireless Connectivity Module received FDA 510(k) clearance under submission number K143414, sponsored by Hill-Rom. 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 2015-03-10.
- Submission: K143414
- Applicant / Sponsor: Hill-Rom
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5170
- Decision date: 2015-03-10
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.