REUSABLE & DISPOSABLE TEMP. PROBES

Thermometer, Electronic, Clinical

ELECTROMEDICS, INC.

The following data is part of a premarket notification filed by Electromedics, Inc. with the FDA for Reusable & Disposable Temp. Probes.

Pre-market Notification Details

Device IDK813459
510k NumberK813459
Device Name:REUSABLE & DISPOSABLE TEMP. PROBES
ClassificationThermometer, Electronic, Clinical
Applicant ELECTROMEDICS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-12-01
Decision Date1982-03-26

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B040XE24252W K813459 000
B040XE21262U K813459 000
B040XE21252T K813459 000
B04024262T K813459 000
B04024242R K813459 000
B04024232Q K813459 000
B04021242O K813459 000
B04021232N K813459 000

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