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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name endoscopic ultrasound system, gastroenterology-urology
510(k) Number K232518
Device Name EndoSound Vision System; EVS
Applicant
Endosound, Inc
4640 S. Macadam Ave Unit 200
Portland,  OR  97239
Applicant Contact Patrick Herriman
Correspondent
Endosound, Inc
4640 S. Macadam Ave Unit 200
Portland,  OR  97239
Correspondent Contact Patrick Herriman
Regulation Number876.1500
Classification Product Code
ODG  
Subsequent Product Codes
ITX   IYN   IYO  
Date Received08/18/2023
Decision Date 12/27/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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