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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 K992362
Device Name FLEXISCOPE IQ 101
Applicant
Schoelly Fiberoptic GmbH
45 Pontiac Rd.
Newton,  MA  02248
Applicant Contact JOSEPH RESS
Correspondent
Schoelly Fiberoptic GmbH
45 Pontiac Rd.
Newton,  MA  02248
Correspondent Contact JOSEPH RESS
Regulation Number876.1500
Classification Product Code
FET  
Date Received07/15/1999
Decision Date 08/05/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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