FDA 510(k), K143513, ZIO SR ECG Monitoring Service
FDA 510(k), K143513, ZIO SR ECG Monitoring Service
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$149.00 USD
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$149.00 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: 12/11/2014
Date Received: 06/19/2015
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: ZIO SR ECG Monitoring Service
Manufacturer: Rich Laguna
Device Classification Name: Recorder, Magnetic Tape, Medical
Regulation Number: DSH
Classification Product Code: 12/11/2014
Date Received: 06/19/2015
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular