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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K971528
Device Name ENDOSCOPICALLY DELIVERALBE ULTRASOUND POINT PORBE SYSTEM (ENDOSCOPY)
Applicant
Fujinon, Inc.
399 Park Ave.
New York,  NY  10022
Applicant Contact GARY A ADLER
Correspondent
Fujinon, Inc.
399 Park Ave.
New York,  NY  10022
Correspondent Contact GARY A ADLER
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Codes
ITX   ODG  
Date Received04/28/1997
Decision Date 12/12/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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