DIOTHERM

Thermometer, Electronic, Clinical

SCIENCE REGULATORY SERVICES INTL.

The following data is part of a premarket notification filed by Science Regulatory Services Intl. with the FDA for Diotherm.

Pre-market Notification Details

Device IDK895137
510k NumberK895137
Device Name:DIOTHERM
ClassificationThermometer, Electronic, Clinical
Applicant SCIENCE REGULATORY SERVICES INTL. SUITE 975 1625 K STREET, NW Washington,  DC  20006
ContactMichael Farrow
CorrespondentMichael Farrow
SCIENCE REGULATORY SERVICES INTL. SUITE 975 1625 K STREET, NW Washington,  DC  20006
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-08-16
Decision Date1990-11-16

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