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FDA 510(k), K100468, ZEISS INFRARED 800 WITH FLOW 800 OPTION
FDA 510(k), K100468, ZEISS INFRARED 800 WITH FLOW 800 OPTION
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510(K) Number: K100468
Device Name: ZEISS INFRARED 800 WITH FLOW 800 OPTION
Manufacturer: CARL ZEISS SURGICAL GMBH
Device Classification Name: system, x-ray, angiographic
Regulation Number: 892.1600
Classification Product Code: IZI
Date Received: 02/18/2010
Decision Date: 03/03/2010
Regulation Medical Specialty: Radiology
Device Name: ZEISS INFRARED 800 WITH FLOW 800 OPTION
Manufacturer: CARL ZEISS SURGICAL GMBH
Device Classification Name: system, x-ray, angiographic
Regulation Number: 892.1600
Classification Product Code: IZI
Date Received: 02/18/2010
Decision Date: 03/03/2010
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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