Cleared Traditional

K914543 - ST5500 UNIVERSAL CARE STRETCHER
(FDA 510(k) Clearance)

Jan 1992
Decision
90d
Days
Class 2
Risk

K914543 is an FDA 510(k) clearance for the ST5500 UNIVERSAL CARE STRETCHER. This device is classified as a Stretcher, Wheeled (Class II - Special Controls, product code FPO).

Submitted by Lic Care, Inc. (Arlington Heights, US). The FDA issued a Cleared decision on January 8, 1992, 90 days after receiving the submission on October 10, 1991.

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

Submission Details

510(k) Number K914543 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 1991
Decision Date January 08, 1992
Days to Decision 90 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

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

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