Cleared Traditional

K932663 - MEDLINE A/C POWERED HEALTHCARE BEDS & ACCESSORIES (FDA 510(k) Clearance)

Nov 1993
Decision
181d
Days
Class 2
Risk

K932663 is an FDA 510(k) clearance for the MEDLINE A/C POWERED HEALTHCARE BEDS & ACCESSORIES. This device is classified as a Bed, Ac-powered Adjustable Hospital (Class II - Special Controls, product code FNL).

Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on November 30, 1993, 181 days after receiving the submission on June 2, 1993.

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

Submission Details

510(k) Number K932663 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1993
Decision Date November 30, 1993
Days to Decision 181 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