EndoTool IV 1.10

Calculator, Drug Dose

Monarch Medical Technologies, LLC

The following data is part of a premarket notification filed by Monarch Medical Technologies, Llc with the FDA for Endotool Iv 1.10.

Pre-market Notification Details

Device IDK200443
510k NumberK200443
Device Name:EndoTool IV 1.10
ClassificationCalculator, Drug Dose
Applicant Monarch Medical Technologies, LLC 4400 Stuart Andrew Blvd, Suite N Charlotte,  NC  28217
ContactAnn Marie Gaitan
CorrespondentPrithul Bom
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeNDC  
CFR Regulation Number868.1890 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyAnesthesiology
510k Review PanelClinical Chemistry
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2020-02-24
Decision Date2020-03-17

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