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FDA 510(k), K131895, AIRVO 2 HUMIDIFIER, MYAIRVO 2 HUMIDIFIER
FDA 510(k), K131895, AIRVO 2 HUMIDIFIER, MYAIRVO 2 HUMIDIFIER
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510(K) Number: K131895
Device Name: AIRVO 2 HUMIDIFIER, MYAIRVO 2 HUMIDIFIER
Manufacturer: BRETT WHISTON
Device Classification Name: Humidifier, Respiratory Gas, (Direct Patient Interface)
Regulation Number: BTT
Classification Product Code: KXA
Date Received: 06/25/2013
Decision Date: 10/24/2013
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
Device Name: AIRVO 2 HUMIDIFIER, MYAIRVO 2 HUMIDIFIER
Manufacturer: BRETT WHISTON
Device Classification Name: Humidifier, Respiratory Gas, (Direct Patient Interface)
Regulation Number: BTT
Classification Product Code: KXA
Date Received: 06/25/2013
Decision Date: 10/24/2013
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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