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510(k) K173156

Integrated CardioRespiratory System by Sensydia, Inc. — Product Code MWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 2018
Date Received
September 29, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocardiograph, Ambulatory (Without Analysis)
Device Class
Class II
Regulation Number
870.2800
Review Panel
CV
Submission Type

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