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Magnum 800 Management System

by The Medical Group, Inc.

510(k) K881844

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK881844 Date14 Jul 1988ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Magnum 800(Tm) Management System
510(k) Number
FDA Product Code
FNL
Device Class
Class II
Regulation
21 CFR Part 880.5100
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Magnum 800 Management System is a Class II medical device classified under product code FNL for bed, ac-powered adjustable hospital use. It is designed for general hospital settings and received FDA 510(k) clearance as substantially equivalent.

The device is supplied by The Medical Group, Inc. and received FDA clearance on July 14, 1988. It is not third party reviewed and is intended for hospital use. No information regarding sterility, single-use or reusable status, MRI safety, or storage conditions is provided in the device data.

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