Cleared Traditional

DRAGER DVE 8080/81/82 WITH DVE 4002 OR DVE 4001 SERIES SYSTEM

K961742 · Alm Surgical Equipment, Inc. · General & Plastic Surgery

Jul 1996

Decision

81d

Days

Class 1

Risk

About This 510(k) Submission

K961742 is an FDA 510(k) clearance for the DRAGER DVE 8080/81/82 WITH DVE 4002 OR DVE 4001 SERIES SYSTEM, 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 26, 1996, 81 days after receiving the submission on May 6, 1996. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4960.

Submission Details

510(k) Number	K961742 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 06, 1996
Decision Date	July 26, 1996
Days to Decision	81 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF