Cleared Traditional

K962871 - ODS1 - HOOD DRIVER
(FDA 510(k) Clearance)

K962871 · Reimers Systems, Inc. · Anesthesiology

Oct 1996

Decision

92d

Days

Class 2

Risk

K962871 is an FDA 510(k) clearance for the ODS1 - HOOD DRIVER, a Chamber, Hyperbaric (Class II — Special Controls, product code CBF), submitted by Reimers Systems, Inc. (Springfield, US). The FDA issued a Cleared decision on October 23, 1996, 92 days after receiving the submission on July 23, 1996. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5470.

Submission Details

510(k) Number	K962871 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 23, 1996
Decision Date	October 23, 1996
Days to Decision	92 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF