FDA 510(k), K202365, Pentax Medical Video Duodenoscope ED32-i10

FDA 510(k), K202365, Pentax Medical Video Duodenoscope ED32-i10

Regular price $570.91 USD
Regular price Sale price $570.91 USD
Sale Sold out
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
View full details