Cleared Traditional

K924275 - RESTRAINING STRETCHER
(FDA 510(k) Clearance)

Jul 1993
Decision
336d
Days
Class 1
Risk

K924275 is an FDA 510(k) clearance for the RESTRAINING STRETCHER. This device is classified as a Stretcher, Hand-carried (Class I - General Controls, product code FPP).

Submitted by Dms (Soiux Falls, US). The FDA issued a Cleared decision on July 27, 1993, 336 days after receiving the submission on August 25, 1992.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6900.

Submission Details

510(k) Number K924275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1992
Decision Date July 27, 1993
Days to Decision 336 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FPP — Stretcher, Hand-carried
Device Class Class I - General Controls
CFR Regulation 21 CFR 880.6900