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FDA 510(k), K121975, AIRVO HUMIDIFIER MYAIRO HUMIDIFIER
FDA 510(k), K121975, AIRVO HUMIDIFIER MYAIRO HUMIDIFIER
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510(K) Number: K121975
Device Name: AIRVO HUMIDIFIER MYAIRO HUMIDIFIER
Manufacturer: BRETT WHISTON
Device Classification Name: Humidifier, Respiratory Gas, (Direct Patient Interface)
Regulation Number: BTT
Classification Product Code: KXA
Date Received: 07/05/2012
Decision Date: 01/03/2013
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
Device Name: AIRVO HUMIDIFIER MYAIRO HUMIDIFIER
Manufacturer: BRETT WHISTON
Device Classification Name: Humidifier, Respiratory Gas, (Direct Patient Interface)
Regulation Number: BTT
Classification Product Code: KXA
Date Received: 07/05/2012
Decision Date: 01/03/2013
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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