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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 K961365
Device Name ENDOCARE ELECTORNIC THERMOMETER SYSTEM
Applicant
Endocare, Inc.
18 Technology Dr., Suite 134
Irvine,  CA  92718
Applicant Contact PAUL MIKUS
Correspondent
Endocare, Inc.
18 Technology Dr., Suite 134
Irvine,  CA  92718
Correspondent Contact PAUL MIKUS
Regulation Number880.2910
Classification Product Code
FLL  
Date Received04/09/1996
Decision Date 08/15/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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