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FDA 510(k)

InPen Dose Calculator

K-Number: K181327 · 2018-07-06

ApplicantCompanion Medical, Inc.
Decision Date2018-07-06
Product CodeNDC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

InPen Dose Calculator is a medical device manufactured by Companion Medical, Inc.. It received FDA 510(k) clearance on 2018-07-06 under approval number K181327. The device is classified under product code NDC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the InPen Dose Calculator?

InPen Dose Calculator is a medical device that received FDA 510(k) clearance on 2018-07-06. It is manufactured by Companion Medical, Inc.. The 510(k) number is K181327.

When was InPen Dose Calculator approved by the FDA?

InPen Dose Calculator received FDA 510(k) clearance on 2018-07-06, under approval number K181327.

What company makes InPen Dose Calculator?

InPen Dose Calculator is manufactured by Companion Medical, Inc..

What is the FDA product code for InPen Dose Calculator?

The FDA product code for InPen Dose Calculator is NDC.

Other Devices by Companion Medical, Inc.

K160629InPen K201337InPen System K190487InPen Dose Calculator K192841InPen System

Related Devices (Code: NDC)

K160949Go Dose SystemEli Lilly and Company K161433Insulia Diabetes Management CompanionVoluntis Sa. K172177Insulia Diabetes Management CompanionVoluntis Sa. K163664Health-e-Connect System with IDAAlr Technologies K152300GlucommanderGlytec, LLC K170669Insulia Diabetes Management CompanionVoluntis Sa.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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