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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 the device name listed in this FDA 510(k) record. The listed applicant is Companion Medical, Inc.. It received FDA 510(k) clearance on 2018-07-06 under 510(k) 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. The listed applicant is Companion Medical, Inc.. The 510(k) number is K181327.

When did InPen Dose Calculator receive FDA 510(k) clearance?

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

Who is the listed applicant for InPen Dose Calculator?

The FDA 510(k) record lists Companion Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for InPen Dose Calculator?

The FDA product code for InPen Dose Calculator is NDC.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05515939Evaluating the InPen in Pediatric Type 1 DiabetesACTIVE_NOT_RECRUITING

Other records listing Companion Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K201337InPen SystemK190487InPen Dose CalculatorK192841InPen SystemK160629InPen

Related Devices (Code: NDC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254102GlucommanderGlytec, LLCK260910EndoTool IV Cloud 1.0Glooko, Inc.K253512MiniMed Go AppMedtronic MinimedK253281UpDocUpdoc, Inc.K252104T1D1Comerge AGK241088EndoTool IV (3.1)Monarch Medical Technologies

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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