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FDA 510(k), K202365, Pentax Medical Video Duodenoscope ED32-i10
FDA 510(k), K202365, Pentax Medical Video Duodenoscope ED32-i10
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$570.91 USD
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$570.91 USD
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510(K) Number: K202365
Device Name: Pentax Medical Video Duodenoscope ED32-i10
Manufacturer: Pentax of America, Inc.
Device Classification Name: Duodenoscope And Accessories, Flexible/Rigid
Regulation Number: 876.1500
Classification Product Code: FDT
Date Received: 08/19/2020
Decision Date: 04/01/2021
Regulation Medical Specialty: Gastroenterology/Urology
Total Pages: 3,843
Fully Redacted Pages: 3,610
Content Pages: 233
Device Name: Pentax Medical Video Duodenoscope ED32-i10
Manufacturer: Pentax of America, Inc.
Device Classification Name: Duodenoscope And Accessories, Flexible/Rigid
Regulation Number: 876.1500
Classification Product Code: FDT
Date Received: 08/19/2020
Decision Date: 04/01/2021
Regulation Medical Specialty: Gastroenterology/Urology
Total Pages: 3,843
Fully Redacted Pages: 3,610
Content Pages: 233
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