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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thermometer, Electronic, Clinical
510(k) Number K833158
Device Name BSD-200
Applicant
BSD MEDICAL CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
BSD MEDICAL CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number880.2910
Classification Product Code
FLL  
Date Received09/16/1983
Decision Date 03/30/1984
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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