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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 K895703
Device Name DIATEK MODEL 700 THERMOMETER
Applicant
Diatek, Inc.
5720 Oberlin Dr.
San Diego,  CA  92121
Applicant Contact C RICHARDSON
Correspondent
Diatek, Inc.
5720 Oberlin Dr.
San Diego,  CA  92121
Correspondent Contact C RICHARDSON
Regulation Number880.2910
Classification Product Code
FLL  
Date Received09/22/1989
Decision Date 12/07/1989
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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