DIATEK MODEL 700 THERMOMETER

Thermometer, Electronic, Clinical

DIATEK, INC.

The following data is part of a premarket notification filed by Diatek, Inc. with the FDA for Diatek Model 700 Thermometer.

Pre-market Notification Details

Device IDK895703
510k NumberK895703
Device Name:DIATEK MODEL 700 THERMOMETER
ClassificationThermometer, Electronic, Clinical
Applicant DIATEK, INC. 5720 OBERLIN DR. San Diego,  CA  92121 -1723
ContactC Richardson
CorrespondentC Richardson
DIATEK, INC. 5720 OBERLIN DR. San Diego,  CA  92121 -1723
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-09-22
Decision Date1989-12-07

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