FDA 510(k), K173156, Integrated CardioRespiratory System
FDA 510(k), K173156, Integrated CardioRespiratory System
510(K) Number: K173156
Device Name: Integrated CardioRespiratory System
Manufacturer: Sensydia, Inc.
Device Classification Name: Electrocardiograph, Ambulatory (Without Analysis)
Regulation Number: 870.2800
Classification Product Code: MWJ
Date Received: 09/29/2017
Decision Date: 06/08/2018
Regulation Medical Specialty: Cardiovascular
Total pages: 3,799
Fully redacted pages: 2,803
Content pages: 996
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