FDA 510(k), K143513, ZIO SR ECG Monitoring Service

FDA 510(k), K143513, ZIO SR ECG Monitoring Service

Regular price $49.00 USD
Regular price Sale price $49.00 USD
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510(K) Number: K143513
Device Name: ZIO SR ECG Monitoring Service
Manufacturer: Rich Laguna
Device Classification Name: Recorder, Magnetic Tape, Medical
Regulation Number: DSH
Classification Product Code: KXA
Date Received: 12/11/2014
Decision Date: 06/19/2015
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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