Active Waste Gas Scavenger

FDA 510(k) K110930 · G. Dundas Co.,Inc.

Substantially Equivalent

510(k) numberK110930

Submission

Device name
Active Waste Gas Scavenger
Applicant
G. Dundas Co.,Inc.
Black Diamond, WA, US
Received
April 4, 2011
Decision date
June 23, 2011
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
CBN – Apparatus, Gas-Scavenging
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5430
Specialty
Anesthesiology

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More from Anesthetic Gas Reclamation, LLC

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K080039Passive Waste Gas Scavenger, Model 14600CBN · Traditional 04/14/2008SE
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Questions and answers

When was Active Waste Gas Scavenger cleared by the FDA?

Active Waste Gas Scavenger (K110930) received a 510(k) decision of Substantially Equivalent on June 23, 2011, 80 days after the submission was received.

What is the product code of K110930?

The FDA product code is CBN – Apparatus, Gas-Scavenging, a Class II (moderate risk) device regulated under 21 CFR 868.5430.