FDA 510(k), K140575, ENGSTROM CARESTATION, ENGSTROM PRO

FDA 510(k), K140575, ENGSTROM CARESTATION, ENGSTROM PRO

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510(K) Number: K140575
Device Name: ENGSTROM CARESTATION, ENGSTROM PRO
Manufacturer: TRISHIA DWYER
Device Classification Name: Ventilator, Continuous, Facility Use
Regulation Number: CBK
Classification Product Code: KXA
Date Received: 03/06/2014
Decision Date: 02/03/2015
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
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