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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name endoscopic video imaging system/component, gastroenterology-urology
510(k) Number K950417
Device Name EPX-310 VIDEO PROCESSOR (ENDOSCOPY)
Applicant
MARKS & MURASE
399 PARK AVE.
NEW YORK,  NY  10022 -4689
Applicant Contact GARY A ADLER
Correspondent
MARKS & MURASE
399 PARK AVE.
NEW YORK,  NY  10022 -4689
Correspondent Contact GARY A ADLER
Regulation Number876.1500
Classification Product Code
FET  
Date Received01/31/1995
Decision Date 07/21/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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