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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 K060421
Device Name SONARA; SONARA/TEK
Applicant
VIASYS HEALTHCARE, INC.
227 WASHINGTON ST. '
SUITE 200
CONSHOHOCKEN,  PA  19428
Applicant Contact GLEN HERMANSON
Correspondent
VIASYS HEALTHCARE, INC.
227 WASHINGTON ST. '
SUITE 200
CONSHOHOCKEN,  PA  19428
Correspondent Contact GLEN HERMANSON
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Code
ITX  
Date Received02/17/2006
Decision Date 11/03/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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