Cleared Special

ACTIVE WASTE GAS SCAVENGER

K110930 · G. Dundas Co.,Inc. · Anesthesiology

Jun 2011

Decision

80d

Days

Class 2

Risk

About This 510(k) Submission

K110930 is an FDA 510(k) clearance for the ACTIVE WASTE GAS SCAVENGER, a Apparatus, Gas-scavenging (Class II — Special Controls, product code CBN), submitted by G. Dundas Co.,Inc. (Black Diamond, US). The FDA issued a Cleared decision on June 23, 2011, 80 days after receiving the submission on April 4, 2011. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5430.

Submission Details

510(k) Number	K110930 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 04, 2011
Decision Date	June 23, 2011
Days to Decision	80 days
Submission Type	Special
Review Panel	Anesthesiology (AN)
Summary	Statement