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FDA 510(k), K160185, Wrist 3
FDA 510(k), K160185, Wrist 3
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510(K) Number: K160185
Device Name: Wrist 3
Manufacturer: ASPECT IMAGING LTD
Device Classification Name: system, nuclear magnetic resonance imaging
Regulation Number: 892.1000
Classification Product Code: LNH
Date Received: 01/27/2016
Decision Date: 03/01/2016
Regulation Medical Specialty: Radiology
Device Name: Wrist 3
Manufacturer: ASPECT IMAGING LTD
Device Classification Name: system, nuclear magnetic resonance imaging
Regulation Number: 892.1000
Classification Product Code: LNH
Date Received: 01/27/2016
Decision Date: 03/01/2016
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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