Cleared Traditional

K143414 - Hill-Rom Wireless Connectivity Module
(FDA 510(k) Clearance)

Mar 2015
Decision
102d
Days
Class 2
Risk

K143414 is an FDA 510(k) clearance for the Hill-Rom Wireless Connectivity Module. This device is classified as a Bed, Flotation Therapy, Powered (Class II - Special Controls, product code IOQ).

Submitted by Hill-Rom (Batesville, US). The FDA issued a Cleared decision on March 10, 2015, 102 days after receiving the submission on November 28, 2014.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5170.

Submission Details

510(k) Number K143414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2014
Decision Date March 10, 2015
Days to Decision 102 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code IOQ — Bed, Flotation Therapy, Powered
Device Class Class II - Special Controls
CFR Regulation 21 CFR 890.5170

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