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FDA 510(k), K162475, mi-eye 2, mi-eye 2 monitor
FDA 510(k), K162475, mi-eye 2, mi-eye 2 monitor
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510(K) Number: K162475
Device Name: mi-eye 2, mi-eye 2 monitor
Manufacturer: Tiffini Diage
Device Classification Name: Arthroscope
Regulation Number: HRX
Classification Product Code: KXA
Date Received: 09/06/2016
Decision Date: 09/16/2016
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: mi-eye 2, mi-eye 2 monitor
Manufacturer: Tiffini Diage
Device Classification Name: Arthroscope
Regulation Number: HRX
Classification Product Code: KXA
Date Received: 09/06/2016
Decision Date: 09/16/2016
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
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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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