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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 K781661
Device Name THERMOMETER, DIGITAL ELEC. MODEL 4755
Applicant
British Aerospace, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
British Aerospace, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.2910
Classification Product Code
FLL  
Date Received09/29/1978
Decision Date 10/17/1978
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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