Cleared Traditional

K883463 - HOSPITAL BED CLOTHING CRADLE
(FDA 510(k) Clearance)

K883463 · Commercial Products & Engineering Co. · General Hospital

Sep 1988

Decision

35d

Days

Class 2

Risk

K883463 is an FDA 510(k) clearance for the HOSPITAL BED CLOTHING CRADLE. This device is classified as a Bed, Ac-powered Adjustable Hospital (Class II — Special Controls, product code FNL).

Submitted by Commercial Products & Engineering Co. (Grand Rapids, US). The FDA issued a Cleared decision on September 19, 1988, 35 days after receiving the submission on August 15, 1988.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5100.

Submission Details

510(k) Number	K883463 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 15, 1988
Decision Date	September 19, 1988
Days to Decision	35 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	—