Active Waste Gas Scavenger
FDA 510(k) K110930 · G. Dundas Co.,Inc.
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
Device classification
- Product code
- CBN – Apparatus, Gas-Scavenging
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5430
- Specialty
- Anesthesiology
Other 510(k)s with product code CBN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K223452 | Nitronox Scavenger PlusCBN · Traditional | Parker Hannifin Corporation | 03/05/2023SE |
| K193646 | Dynamic Gas Scavenging System 2 (DGSS - 2)CBN · Special | Anesthetic Gas Reclamation, Inc. | 12/04/2020SE |
| K160950 | MiniscavCBN · Traditional | Sedation Systems, LLC | 05/05/2017SE |
| K142138 | Iso-Gard MaskCBN · Traditional | Teleflexmedical, Inc. | 10/30/2014SE |
| K132729 | Iso-Gard MaskCBN · Special | Teleflexmedical, Inc. | 01/09/2014SE |
| K123176 | Iso-Gard Clearair MaskCBN · Traditional | Teleflexmedical, Inc. | 02/14/2013SE |
| K092031 | Vapor-Clear, Model 100CBN · Traditional | Axon Medical, Inc. | 04/16/2010SE |
| K080039 | Passive Waste Gas Scavenger, Model 14600CBN · Traditional | G. Dundas Co.,Inc. | 04/14/2008SE |
| K072255 | Minrad Inc. Nasal Scavenging CircuitCBN · Traditional | Minrad, Inc. | 10/18/2007SE |
| K063519 | Dynamic Gas Scavenging System (DGSS)CBN · Traditional | Anesthetic Gas Reclamation, LLC | 12/01/2006SE |
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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.