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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thermometer, Electronic, Clinical
510(k) Number K011291
FOIA Releasable 510(k) K011291
Device Name TEMPORALSCANNER THERMOMETER, SENSORTOUCH
Applicant
EXERGEN CORP.
601 13TH STREET, NW
WASHINGTON,  DC  20005
Applicant Contact WILLIAM HARE
Correspondent
EXERGEN CORP.
601 13TH STREET, NW
WASHINGTON,  DC  20005
Correspondent Contact WILLIAM HARE
Regulation Number880.2910
Classification Product Code
FLL  
Date Received04/27/2001
Decision Date 07/12/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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