FDA 510(k), K070714, MEDISIZE GOLD HEATER AND BOOSTER

FDA 510(k), K070714, MEDISIZE GOLD HEATER AND BOOSTER

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510(K) Number: K070714
Device Name: MEDISIZE GOLD HEATER AND BOOSTER
Manufacturer: SOPHIA LAM
Device Classification Name: Humidifier, Respiratory Gas, (Direct Patient Interface)
Regulation Number: BTT
Classification Product Code: 03/14/2007
Date Received: 04/30/2007
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
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