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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Tomography, Computed, Emission
510(k) Number K040057
Device Name MOBILE COMPACT DIGITAL CARDIAC CAMERA
Applicant
Is2 Research, Inc.
20 Gurdwara Rd.
Units 3-10
Ottawa, Ontario,  CA K2E 8B3
Applicant Contact VICTOR WOODBURN
Correspondent
Is2 Research, Inc.
20 Gurdwara Rd.
Units 3-10
Ottawa, Ontario,  CA K2E 8B3
Correspondent Contact VICTOR WOODBURN
Regulation Number892.1200
Classification Product Code
KPS  
Date Received01/13/2004
Decision Date 02/02/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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