Cleared Traditional

K863694 - BED/ADJUST/HOSPITAL/FOLDING FIELD WITHOUT MATTRESS (FDA 510(k) Clearance)

Jan 1987
Decision
123d
Days
Class 1
Risk

K863694 is an FDA 510(k) clearance for the BED/ADJUST/HOSPITAL/FOLDING FIELD WITHOUT MATTRESS. This device is classified as a Bed, Manual (Class I - General Controls, product code FNJ).

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 880.5120.

Submission Details

510(k) Number K863694 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 FNJ — Bed, Manual
Device Class Class I - General Controls
CFR Regulation 21 CFR 880.5120