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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 K883793
Device Name DISPOSABLE TEMPERATURE PROBES (SEVERAL MODELS)
Applicant
Yellow Springs Instrument Co., Inc.
1725 Brannum Ln.
Yellow Springs,  OH  45387
Applicant Contact FRED BREIDT
Correspondent
Yellow Springs Instrument Co., Inc.
1725 Brannum Ln.
Yellow Springs,  OH  45387
Correspondent Contact FRED BREIDT
Regulation Number880.2910
Classification Product Code
FLL  
Date Received09/07/1988
Decision Date 11/21/1988
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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