510(k) K143414

Hill-Rom Wireless Connectivity Module by Hill-Rom — Product Code IOQ

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