Cleared Traditional

PEDIATRIC HOSPITAL BED

K881843 · The Medical Group, Inc. · Physical Medicine
Oct 1988
Decision
177d
Days
Class 2
Risk

About This 510(k) Submission

K881843 is an FDA 510(k) clearance for the PEDIATRIC HOSPITAL BED, a Bed, Flotation Therapy, Powered (Class II — Special Controls, product code IOQ), submitted by The Medical Group, Inc. (Buena Park, US). The FDA issued a Cleared decision on October 26, 1988, 177 days after receiving the submission on May 2, 1988. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5170.

Submission Details

510(k) Number K881843 FDA.gov
FDA Decision Cleared SESE
Date Received May 02, 1988
Decision Date October 26, 1988
Days to Decision 177 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary —

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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