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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 K840648
Device Name TEMPROBE MONITOR
Applicant
VITAL SIGNS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
VITAL SIGNS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number880.2910
Classification Product Code
FLL  
Date Received02/15/1984
Decision Date 06/05/1984
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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