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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 K042326
Device Name ERGOSONIX ULTRASOUND SCANNER, MODULO ULTRASOUND SCANNER
Applicant
UltraSonix Medical Corporation
310-3480 GILMORE WAY
BURNABY, BRITISH COLUMBIA,  CA V5G 4Y1
Applicant Contact IULIA NUCA
Correspondent
UltraSonix Medical Corporation
310-3480 GILMORE WAY
BURNABY, BRITISH COLUMBIA,  CA V5G 4Y1
Correspondent Contact IULIA NUCA
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received08/27/2004
Decision Date 09/16/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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