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FDA 510(k)

InPen System

K-Number: K201337 · 2020-06-18

ApplicantCompanion Medical, Inc.
Decision Date2020-06-18
Product CodeNDC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

InPen System is a medical device manufactured by Companion Medical, Inc.. It received FDA 510(k) clearance on 2020-06-18 under approval number K201337. 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 System?

InPen System is a medical device that received FDA 510(k) clearance on 2020-06-18. It is manufactured by Companion Medical, Inc.. The 510(k) number is K201337.

When was InPen System approved by the FDA?

InPen System received FDA 510(k) clearance on 2020-06-18, under approval number K201337.

What company makes InPen System?

InPen System is manufactured by Companion Medical, Inc..

What is the FDA product code for InPen System?

The FDA product code for InPen System is NDC.

Other Devices by Companion Medical, Inc.

K160629InPen K181327InPen Dose Calculator K190487InPen Dose Calculator K192841InPen System

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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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