MODEL 2082 TEMP PLUS III THERMOMETER/MODEL 2087 TEMP PLUS III WALL MOUNT THERMOMETER

Thermometer, Electronic, Clinical

Y

The following data is part of a premarket notification filed by Y with the FDA for Model 2082 Temp Plus Iii Thermometer/model 2087 Temp Plus Iii Wall Mount Thermometer.

Pre-market Notification Details

Device IDK955846
510k NumberK955846
Device Name:MODEL 2082 TEMP PLUS III THERMOMETER/MODEL 2087 TEMP PLUS III WALL MOUNT THERMOMETER
ClassificationThermometer, Electronic, Clinical
Applicant Y 10300 CAMPUS POINT DR. San Diego,  CA  92121 -1579
ContactJennifer S Hankard
CorrespondentJennifer S Hankard
Y 10300 CAMPUS POINT DR. San Diego,  CA  92121 -1579
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-12-26
Decision Date1996-10-01
Summary:summary

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