Cleared Traditional

DRAGER DVE 8000/1/2 SERIES SYST W/DVE 4002 AND 8032E

K942043 · Alm Surgical Equipment, Inc. · General & Plastic Surgery

Jul 1994

Decision

76d

Days

Class 1

Risk

About This 510(k) Submission

K942043 is an FDA 510(k) clearance for the DRAGER DVE 8000/1/2 SERIES SYST W/DVE 4002 AND 8032E, a Table, Operating-room, Ac-powered (Class I — General Controls, product code FQO), submitted by Alm Surgical Equipment, Inc. (Anaheim, US). The FDA issued a Cleared decision on July 13, 1994, 76 days after receiving the submission on April 28, 1994. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4960.

Submission Details

510(k) Number	K942043 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 28, 1994
Decision Date	July 13, 1994
Days to Decision	76 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF