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 IDK201337
510k NumberK201337
Device Name:InPen System
ClassificationCalculator, Drug Dose
Applicant Companion Medical, Inc. 12230 World Trade Drive, Suite 100 San Diego,  CA  92128
ContactJasper Benke
CorrespondentJasper Benke
Companion Medical, Inc. 12230 World Trade Drive, Suite 100 San Diego,  CA  92128
Product CodeNDC  
CFR Regulation Number868.1890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-20
Decision Date2020-06-18

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