Cleared Traditional

K922352 - THE ADVANCE SERIES FROM HILL-ROM (FDA 510(k) Clearance)

Oct 1992
Decision
147d
Days
Class 2
Risk

K922352 is an FDA 510(k) clearance for the THE ADVANCE SERIES FROM HILL-ROM. This device is classified as a Bed, Ac-powered Adjustable Hospital (Class II - Special Controls, product code FNL).

Submitted by Hill-Rom, Inc. (Batesville, US). The FDA issued a Cleared decision on October 13, 1992, 147 days after receiving the submission on May 19, 1992.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5100.

Submission Details

510(k) Number K922352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1992
Decision Date October 13, 1992
Days to Decision 147 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FNL — Bed, Ac-powered Adjustable Hospital
Device Class Class II - Special Controls
CFR Regulation 21 CFR 880.5100