Cleared Traditional

KING KRIB

K934298 · Noritage, Inc. · General Hospital

Jan 1994

Decision

146d

Days

Class 1

Risk

About This 510(k) Submission

K934298 is an FDA 510(k) clearance for the KING KRIB, a Bed, Manual (Class I — General Controls, product code FNJ), submitted by Noritage, Inc. (Great Neck,, US). The FDA issued a Cleared decision on January 26, 1994, 146 days after receiving the submission on September 2, 1993. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5120.

Submission Details

510(k) Number	K934298 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 02, 1993
Decision Date	January 26, 1994
Days to Decision	146 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement