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FDA 510(k), K153289, HEALTHMYNE
FDA 510(k), K153289, HEALTHMYNE
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510(K) Number: K153289
Device Name: HEALTHMYNE
Manufacturer: HEALTHMYNE, INC
Device Classification Name: system, image processing, radiological
Regulation Number: 892.2050
Classification Product Code: LLZ
Date Received: 11/13/2015
Decision Date: 01/15/2016
Regulation Medical Specialty: Radiology
Device Name: HEALTHMYNE
Manufacturer: HEALTHMYNE, INC
Device Classification Name: system, image processing, radiological
Regulation Number: 892.2050
Classification Product Code: LLZ
Date Received: 11/13/2015
Decision Date: 01/15/2016
Regulation Medical Specialty: Radiology
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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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