InPen System

Calculator, Drug Dose

Companion Medical, Inc.

The following data is part of a premarket notification filed by Companion Medical, Inc. with the FDA for Inpen System.

Pre-market Notification Details

Device IDK192841
510k NumberK192841
Device Name:InPen System
ClassificationCalculator, Drug Dose
Applicant Companion Medical, Inc. 11011 Via Frontera, Suite D San Diego,  CA  92127
ContactJasper Benke
CorrespondentJasper Benke
Companion Medical, Inc. 11011 Via Frontera, Suite D San Diego,  CA  92127
Product CodeNDC  
CFR Regulation Number868.1890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2019-10-03
Decision Date2020-02-10

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