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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Thermographic, Liquid Crystal, Powered (Adjunctive Use)
510(k) Number K843124
Device Name Q-SCAN THERMOGRAPHY SYSTEM
Applicant
Qmax Medical, Inc.
P.O. Box 1181
Dayton,  OH  45401 -
Applicant Contact JULIAN M MENDOZA
Correspondent
Qmax Medical, Inc.
P.O. Box 1181
Dayton,  OH  45401 -
Correspondent Contact JULIAN M MENDOZA
Regulation Number884.2982
Classification Product Code
KXZ  
Date Received08/08/1984
Decision Date 11/29/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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