Iso-Gard Mask
FDA 510(k) K142138 · Teleflexmedical, Inc.
510(k) numberK142138
Submission
- Device name
- Iso-Gard Mask
- Applicant
- Teleflexmedical, Inc.
Durham, NC, US - Received
- August 5, 2014
- Decision date
- October 30, 2014
- 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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| K132729 | Iso-Gard MaskCBN · Special | Teleflexmedical, Inc. | 01/09/2014SE |
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| K110930 | Active Waste Gas ScavengerCBN · Special | G. Dundas Co.,Inc. | 06/23/2011SE |
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Questions and answers
When was Iso-Gard Mask cleared by the FDA?
Iso-Gard Mask (K142138) received a 510(k) decision of Substantially Equivalent on October 30, 2014, 86 days after the submission was received.
What is the product code of K142138?
The FDA product code is CBN – Apparatus, Gas-Scavenging, a Class II (moderate risk) device regulated under 21 CFR 868.5430.