InPen Dose Calculator

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 Dose Calculator.

Pre-market Notification Details

Device IDK181327
510k NumberK181327
Device Name:InPen Dose Calculator
ClassificationCalculator, Drug Dose
Applicant Companion Medical, Inc. 16486 Bernardo Center Drive, # 300 San Diego,  CA  92128
ContactJasper Benke
CorrespondentJasper Benke
Companion Medical, Inc. 16486 Bernardo Center Drive, # 300 San Diego,  CA  92128
Product CodeNDC  
CFR Regulation Number868.1890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-05-18
Decision Date2018-07-06
Summary:summary

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