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FDA 510(k), K001241, EVIS EXERA COLONOVIDEOSCOPE CF-Q160 AL/I AND PCF-160 AL/I
FDA 510(k), K001241, EVIS EXERA COLONOVIDEOSCOPE CF-Q160 AL/I AND PCF-160 AL/I
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510(K) Number: K001241
Device Name: EVIS EXERA COLONOVIDEOSCOPE CF-Q160 AL/I AND PCF-160 AL/I
Manufacturer: LAURA STORMS-TYLER
Device Classification Name: Colonoscope And Accessories, Flexible/Rigid
Regulation Number: FDF
Classification Product Code: 04/18/2000
Date Received: 05/09/2000
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: EVIS EXERA COLONOVIDEOSCOPE CF-Q160 AL/I AND PCF-160 AL/I
Manufacturer: LAURA STORMS-TYLER
Device Classification Name: Colonoscope And Accessories, Flexible/Rigid
Regulation Number: FDF
Classification Product Code: 04/18/2000
Date Received: 05/09/2000
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
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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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