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510(k) Submission Records – K173156
510(k) Submission Records – K173156
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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
Request Contents: FDA 510(k) submission records for 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
Request Contents: FDA 510(k) submission records for K173156.
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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