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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Telethermographic (Adjunctive Use)
510(k) Number K011981
Device Name MHS 5000
Applicant
Micro Health Systems, Inc.
7407 Dover Ln.
Parkland,  FL  33067
Applicant Contact ROBERT BARNES
Correspondent
Micro Health Systems, Inc.
7407 Dover Ln.
Parkland,  FL  33067
Correspondent Contact ROBERT BARNES
Regulation Number884.2980
Classification Product Code
LHQ  
Date Received06/25/2001
Decision Date 09/05/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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