Cleared Traditional

MAGNUM 800(TM) MANAGEMENT SYSTEM

K881844 · The Medical Group, Inc. · General Hospital
Jul 1988
Decision
73d
Days
Class 2
Risk

About This 510(k) Submission

K881844 is an FDA 510(k) clearance for the MAGNUM 800(TM) MANAGEMENT SYSTEM, a Bed, Ac-powered Adjustable Hospital (Class II — Special Controls, product code FNL), submitted by The Medical Group, Inc. (Buena Park, US). The FDA issued a Cleared decision on July 14, 1988, 73 days after receiving the submission on May 2, 1988. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5100.

Submission Details

510(k) Number K881844 FDA.gov
FDA Decision Cleared SESE
Date Received May 02, 1988
Decision Date July 14, 1988
Days to Decision 73 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

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

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