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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 K993750
Device Name PROSOLV ECHOVIEWER, PROSOLV ECHOVIEWER SE, PROSOLV ECHOANALYZER, PROSOLV ECHOSERV, PROSOLV ECHO
Applicant
Problem Solving Concepts, Inc.
1980 E. 116th St.
Suite 220
Carmel,  IN  46032
Applicant Contact THOMAS M MCCLELLAND
Correspondent
Problem Solving Concepts, Inc.
1980 E. 116th St.
Suite 220
Carmel,  IN  46032
Correspondent Contact THOMAS M MCCLELLAND
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/05/1999
Decision Date 02/02/2000
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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