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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 K852301
Device Name INOX THERMOMETER JAR
Applicant
Broadwest Corp.
260 W. Broadway
New York,  NY  10013
Applicant Contact JACK DONOVAN
Correspondent
Broadwest Corp.
260 W. Broadway
New York,  NY  10013
Correspondent Contact JACK DONOVAN
Regulation Number880.2920
Classification Product Code
FLK  
Date Received05/29/1985
Decision Date 07/01/1985
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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