FDA 510(k), K171816, Kardia Band System

FDA 510(k), K171816, Kardia Band System

Regular price $49.00 USD
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510(K) Number: K171816
Device Name: Kardia Band System
Manufacturer: Prabhu Raghavan
Device Classification Name: Transmitters And Receivers, Electrocardiograph, Telephone
Regulation Number: DXH
Classification Product Code: KXA
Date Received: 06/19/2017
Decision Date: 11/16/2017
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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