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FDA 510(k), K093288, CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION
FDA 510(k), K093288, CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION
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510(K) Number: K093288
Device Name: CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION
Manufacturer: CARDIONET, INC
Device Classification Name: outpatient cardiac telemetry
Regulation Number: 870.1025
Classification Product Code: QYX
Date Received: 10/20/2009
Decision Date: 04/08/2010
Regulation Medical Specialty: Cardiovascular
Device Name: CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION
Manufacturer: CARDIONET, INC
Device Classification Name: outpatient cardiac telemetry
Regulation Number: 870.1025
Classification Product Code: QYX
Date Received: 10/20/2009
Decision Date: 04/08/2010
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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