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FDA 510(k), K101491, UROSKOP OMNIA
FDA 510(k), K101491, UROSKOP OMNIA
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510(K) Number: K101491
Device Name: UROSKOP OMNIA
Manufacturer: SIEMENS MEDICAL SOLUTIONS USA, INC.
Device Classification Name: system, x-ray, fluoroscopic, image-intensified
Regulation Number: 892.1650
Classification Product Code: JAA
Date Received: 06/01/2010
Decision Date: 06/30/2010
Regulation Medical Specialty: Radiology
Device Name: UROSKOP OMNIA
Manufacturer: SIEMENS MEDICAL SOLUTIONS USA, INC.
Device Classification Name: system, x-ray, fluoroscopic, image-intensified
Regulation Number: 892.1650
Classification Product Code: JAA
Date Received: 06/01/2010
Decision Date: 06/30/2010
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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