Cleared Traditional

K974296 - MODEL 720 SERIES FULL/SEMI ELECTRIC BED 1120 FULL ELECTRIC BED
(FDA 510(k) Clearance)

K974296 · Invacare Corp. · General Hospital
Jan 1998
Decision
50d
Days
Class 2
Risk

K974296 is an FDA 510(k) clearance for the MODEL 720 SERIES FULL/SEMI ELECTRIC BED 1120 FULL ELECTRIC BED, a Bed, Ac-powered Adjustable Hospital (Class II — Special Controls, product code FNL), submitted by Invacare Corp. (Elyria, US). The FDA issued a Cleared decision on January 6, 1998, 50 days after receiving the submission on November 17, 1997. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5100.

Submission Details

510(k) Number K974296 FDA.gov
FDA Decision Cleared SESE
Date Received November 17, 1997
Decision Date January 06, 1998
Days to Decision 50 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

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