Iso-Gard Clearair Mask
FDA 510(k) K123176 · Teleflexmedical, Inc.
510(k) numberK123176
Submission
- Device name
- Iso-Gard Clearair Mask
- Applicant
- Teleflexmedical, Inc.
Research Triangle Park, NC, US - Received
- October 10, 2012
- Decision date
- February 14, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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| K110930 | Active Waste Gas ScavengerCBN · Special | G. Dundas Co.,Inc. | 06/23/2011SE |
| 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 Iso-Gard Clearair Mask cleared by the FDA?
Iso-Gard Clearair Mask (K123176) received a 510(k) decision of Substantially Equivalent on February 14, 2013, 127 days after the submission was received.
What is the product code of K123176?
The FDA product code is CBN – Apparatus, Gas-Scavenging, a Class II (moderate risk) device regulated under 21 CFR 868.5430.