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FDA 510(k) K143646, MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb Circuit, by Fisher & Paykel Healthcare, Ltd.

FDA 510(k) K143646, MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb Circuit, by Fisher & Paykel Healthcare, Ltd.

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510(K) Number: K143646
Device Name: MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb Circuit
Manufacturer: Fisher & Paykel Healthcare, Ltd.
Device Classification Name: humidifier, respiratory gas, (direct patient interface)
Regulation Number: 868.5450
Classification Product Code: BTT
Date Received: 12/22/2014
Decision Date: 03/05/2015
Regulation Medical Specialty: Anesthesiology
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