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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Continuous Measurement Thermometer
510(k) Number K852825
Device Name TMA TEMPERATURE MONITOR
Applicant
FERGUSON MEDICAL
3407 BAY AVE.
CHICO,  CA  95973 -8619
Applicant Contact FRANK FERGUSON
Correspondent
FERGUSON MEDICAL
3407 BAY AVE.
CHICO,  CA  95973 -8619
Correspondent Contact FRANK FERGUSON
Regulation Number880.2910
Classification Product Code
FLL  
Date Received07/01/1985
Decision Date 12/03/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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