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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thermometer, Clinical Mercury
510(k) Number K932991
Device Name GUARDIAN AND ANDINO MODELS
Applicant
Coltemp, Inc.
8900 SW 107 Ave. Suite 311
Miami,  FL  33176
Applicant Contact MANUEL MEDINA
Correspondent
Coltemp, Inc.
8900 SW 107 Ave. Suite 311
Miami,  FL  33176
Correspondent Contact MANUEL MEDINA
Regulation Number880.2920
Classification Product Code
FLK  
Date Received06/18/1993
Decision Date 01/28/1994
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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