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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 K813409
Device Name MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER
Applicant
Yellow Springs Instrument Co., Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Yellow Springs Instrument Co., Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number880.2910
Classification Product Code
FLL  
Date Received12/04/1981
Decision Date 12/18/1981
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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