Cleared Traditional

K843439 - CENTURIAN HYDRAULIC STRETCHER
(FDA 510(k) Clearance)

Sep 1984
Decision
9d
Days
Class 2
Risk

K843439 is an FDA 510(k) clearance for the CENTURIAN HYDRAULIC STRETCHER. This device is classified as a Stretcher, Wheeled (Class II - Special Controls, product code FPO).

Submitted by American Sterilizer Co. (Mchenry, US). The FDA issued a Cleared decision on September 13, 1984, 9 days after receiving the submission on September 4, 1984.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6910.

Submission Details

510(k) Number K843439 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1984
Decision Date September 13, 1984
Days to Decision 9 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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