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FDA 510(k), K113862, ZIO PATCH
FDA 510(k), K113862, ZIO PATCH
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510(K) Number: K113862
Device Name: ZIO PATCH
Manufacturer: IRHYTHM TECHNOLOGIES, INC.
Device Classification Name: recorder, magnetic tape, medical
Regulation Number: 870.2800
Classification Product Code: DSH
Date Received: 12/30/2011
Decision Date: 02/06/2012
Regulation Medical Specialty: Cardiovascular
Device Name: ZIO PATCH
Manufacturer: IRHYTHM TECHNOLOGIES, INC.
Device Classification Name: recorder, magnetic tape, medical
Regulation Number: 870.2800
Classification Product Code: DSH
Date Received: 12/30/2011
Decision Date: 02/06/2012
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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