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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 K884119
Device Name TYPE 9230 TEMP 1 & 2 SYSTEM ATHENA
Applicant
S & W Medico Teknik
195 Broadway
New York,  NY  10007
Applicant Contact MICHAEL PULEO
Correspondent
S & W Medico Teknik
195 Broadway
New York,  NY  10007
Correspondent Contact MICHAEL PULEO
Regulation Number880.2910
Classification Product Code
FLL  
Date Received09/30/1988
Decision Date 11/02/1988
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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