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FDA 510(k), K152626, H3+ Holter Recorder
FDA 510(k), K152626, H3+ Holter Recorder
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510(K) Number: K152626
Device Name: H3+ Holter Recorder
Manufacturer: MORTARA INSTRUMENT, INC
Device Classification Name: electrocardiograph, ambulatory (without analysis)
Regulation Number: 870.2800
Classification Product Code: MWJ
Date Received: 09/15/2015
Decision Date: 02/26/2016
Regulation Medical Specialty: Cardiovascular
Device Name: H3+ Holter Recorder
Manufacturer: MORTARA INSTRUMENT, INC
Device Classification Name: electrocardiograph, ambulatory (without analysis)
Regulation Number: 870.2800
Classification Product Code: MWJ
Date Received: 09/15/2015
Decision Date: 02/26/2016
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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