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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 Doppler, Ultrasonic
510(k) Number K051739
Device Name POCKET TRANSCRANIAL AND VASCULAR DOPPLER SPECTRUM ANALYZER, MODEL 500P; PW DOPPLER ULTRAOUND PROBE, MODEL 2MPB.
Applicant
Multigon Industries, Inc.
One Odell Plz.
Yonkers,  NY  10701
Applicant Contact WILLIAM STERN
Correspondent
Multigon Industries, Inc.
One Odell Plz.
Yonkers,  NY  10701
Correspondent Contact WILLIAM STERN
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Code
ITX  
Date Received06/28/2005
Decision Date 07/28/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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