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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 K940380
Device Name AMG MED BRAND CLINICAL GLASS THERMOMETER
Applicant
Amg Medical, Inc.
8531 Delmeade
Montreal, Que H4t 1m1
Canada,  CA
Applicant Contact ANDRE RENAUD
Correspondent
Amg Medical, Inc.
8531 Delmeade
Montreal, Que H4t 1m1
Canada,  CA
Correspondent Contact ANDRE RENAUD
Regulation Number880.2920
Classification Product Code
FLK  
Date Received01/26/1994
Decision Date 05/04/1994
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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