510(k) K143414
K143414 is an FDA 510(k) premarket notification submitted by Hill-Rom for the device "Hill-Rom Wireless Connectivity Module". The FDA issued a decision of Substantially Equivalent on March 10, 2015. The device falls under product code IOQ (Bed, Flotation Therapy, Powered), a Class II device regulated under 21 CFR 890.5170. Hill-Rom has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 10, 2015
- Date Received
- November 28, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bed, Flotation Therapy, Powered
- Device Class
- Class II
- Regulation Number
- 890.5170
- Review Panel
- PM
- Submission Type