Phoenix Digital Thermometer

Thermometer, Electronic, Clinical

Phoenix Innovative Healthcare Manufacturers Pvt. Ltd.

The following data is part of a premarket notification filed by Phoenix Innovative Healthcare Manufacturers Pvt. Ltd. with the FDA for Phoenix Digital Thermometer.

Pre-market Notification Details

Device IDK201032
510k NumberK201032
Device Name:Phoenix Digital Thermometer
ClassificationThermometer, Electronic, Clinical
Applicant Phoenix Innovative Healthcare Manufacturers Pvt. Ltd. EL-209 Shil Mahape Road Electronic Zone MIDC, TTC Industrial Area Mahape, Navi Mumbai,  IN 400710
ContactRamshankar Ghosh
CorrespondentMichael Stuart
Phoenix Healthcare Solutions, LLC 2281 Griffin Road Fort Lauderdale,  FL  33312
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-20
Decision Date2021-10-29

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