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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 K030223
Device Name SONOCALC
Applicant
Sonometric Health, LLC
1373 E. Skyline Dr.
Bountiful,  UT  84010
Applicant Contact HELMUT FRITZ
Correspondent
Entela, Inc.
3033 Madison Ave., SE
Grand Rapids,  MI  49548
Correspondent Contact NED E DEVINE
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received01/22/2003
Decision Date 02/06/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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