Cleared Traditional

K885241 - BED, ADJUSTABLE, HOSPITAL, FOLDING, FIELD, W/O MAT
(FDA 510(k) Clearance)

Feb 1989
Decision
65d
Days
Class 1
Risk

K885241 is an FDA 510(k) clearance for the BED, ADJUSTABLE, HOSPITAL, FOLDING, FIELD, W/O MAT. This device is classified as a Bed, Manual (Class I - General Controls, product code FNJ).

Submitted by King Mfg. Co. (Memphis, US). The FDA issued a Cleared decision on February 24, 1989, 65 days after receiving the submission on December 21, 1988.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5120.

Submission Details

510(k) Number K885241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1988
Decision Date February 24, 1989
Days to Decision 65 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