Cleared Traditional

K863686 - BACK REST, LITTER, NON-ADJUSTABLE (FDA 510(k) Clearance)

Jan 1987
Decision
123d
Days
Class 1
Risk

K863686 is an FDA 510(k) clearance for the BACK REST, LITTER, NON-ADJUSTABLE. This device is classified as a Stretcher, Hand-carried (Class I - General Controls, product code FPP).

Submitted by Brenner Metal Prod Corp. (Wallington, US). The FDA issued a Cleared decision on January 20, 1987, 123 days after receiving the submission on September 19, 1986.

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

Submission Details

510(k) Number K863686 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1986
Decision Date January 20, 1987
Days to Decision 123 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary

Device Classification

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