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FDA 510(k)

Insulia Diabetes Management Companion

K-Number: K161433 · 2016-11-09

ApplicantVoluntis Sa.
Decision Date2016-11-09
Product CodeNDC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Insulia Diabetes Management Companion is the device name listed in this FDA 510(k) record. The listed applicant is Voluntis Sa.. It received FDA 510(k) clearance on 2016-11-09 under 510(k) number K161433. 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 Insulia Diabetes Management Companion?

Insulia Diabetes Management Companion is a medical device that received FDA 510(k) clearance on 2016-11-09. The listed applicant is Voluntis Sa.. The 510(k) number is K161433.

When did Insulia Diabetes Management Companion receive FDA 510(k) clearance?

Insulia Diabetes Management Companion received FDA 510(k) clearance on 2016-11-09, under 510(k) number K161433.

Who is the listed applicant for Insulia Diabetes Management Companion?

The FDA 510(k) record lists Voluntis Sa. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Insulia Diabetes Management Companion?

The FDA product code for Insulia Diabetes Management Companion is NDC.

Other records listing Voluntis Sa. 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.

K250022HeroTracker SenseK232451Insulia Bolus CompanionK202596Insulia Diabetes Management CompanionK172177Insulia Diabetes Management CompanionK170669Insulia Diabetes Management Companion

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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