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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K971776
Device Name ECHOVACS
Applicant
Vmi Technologies
412-126 York St.
Suite 412
Ottawa,Ontario,  CA K1N 5T5
Applicant Contact DOUG SEABORN
Correspondent
Vmi Technologies
412-126 York St.
Suite 412
Ottawa,Ontario,  CA K1N 5T5
Correspondent Contact DOUG SEABORN
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/13/1997
Decision Date 07/14/1997
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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