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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 K934482
Device Name VITAL SIGNS DUAL DISPLAY TEMPERATURE MONITOR, MODEL 1600
Applicant
Vital Signs, Inc.
20 Campus Rd.
Totowa,  NJ  07512
Applicant Contact JING ZHANG
Correspondent
Vital Signs, Inc.
20 Campus Rd.
Totowa,  NJ  07512
Correspondent Contact JING ZHANG
Regulation Number880.2910
Classification Product Code
FLL  
Date Received09/14/1993
Decision Date 05/02/1994
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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