FDA 510(k), K163614, PENTAX Medical ED34-i10T, Video Duodenoscope
FDA 510(k), K163614, PENTAX Medical ED34-i10T, Video Duodenoscope
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$149.00 USD
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510(K) Number: K163614
Device Name: PENTAX Medical ED34-i10T, Video Duodenoscope
Manufacturer:
Device Classification Name: Duodenoscope And Accessories, Flexible/Rigid
Regulation Number: 876.1500
Classification Product Code: FDT
Date Received: 12/22/2016
Decision Date: 09/20/2017
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: PENTAX Medical ED34-i10T, Video Duodenoscope
Manufacturer:
Device Classification Name: Duodenoscope And Accessories, Flexible/Rigid
Regulation Number: 876.1500
Classification Product Code: FDT
Date Received: 12/22/2016
Decision Date: 09/20/2017
Regulation Medical Specialty: Gastroenterology/Urology