EndoTool SubQ 2.1

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 Subq 2.1.

Pre-market Notification Details

Device IDK211160
510k NumberK211160
Device Name:EndoTool SubQ 2.1
ClassificationCalculator, Drug Dose
Applicant Monarch Medical Technologies, LLC 4400 Stuart Andrew Blvd., Suite N Charlotte,  NC  28217
ContactAnn Marie Gaitan
CorrespondentChristophe Mallard
Monarch Medical Technologies, LLC 1924 Cleveland Ave, Ste 201 Charlotte,  NC  28203
Product CodeNDC  
CFR Regulation Number868.1890 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-19
Decision Date2021-10-28

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