Cleared Traditional

MODEL #527 OPHTHALMIC STRETCHER

K904011 · Midmark Corp. · General Hospital
Oct 1990
Decision
35d
Days
Class 2
Risk

About This 510(k) Submission

K904011 is an FDA 510(k) clearance for the MODEL #527 OPHTHALMIC STRETCHER, a Stretcher, Wheeled (Class II — Special Controls, product code FPO), submitted by Midmark Corp. (Versailles, US). The FDA issued a Cleared decision on October 3, 1990, 35 days after receiving the submission on August 29, 1990. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6910.

Submission Details

510(k) Number K904011 FDA.gov
FDA Decision Cleared SESE
Date Received August 29, 1990
Decision Date October 03, 1990
Days to Decision 35 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code FPO — Stretcher, Wheeled
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6910

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