Cleared Traditional

MODEL #535 PACU STRETCHER/BED & #530 ED/TRAUMA STR

K894335 · Midmark Corp. · General Hospital
Sep 1989
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K894335 is an FDA 510(k) clearance for the MODEL #535 PACU STRETCHER/BED & #530 ED/TRAUMA STR, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Midmark Corp. (Versailles, US). The FDA issued a Cleared decision on September 12, 1989, 60 days after receiving the submission on July 14, 1989. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K894335 FDA.gov
FDA Decision Cleared SESE
Date Received July 14, 1989
Decision Date September 12, 1989
Days to Decision 60 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code FMF — Syringe, Piston
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5860

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