FDA 510(k)

Insulin Algorithms System

K-Number: K160673 · 2017-06-07

Decision Date2017-06-07

Product CodeNDC

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

Insulin Algorithms System is the device name listed in this FDA 510(k) record. The listed applicant is Insulin Algorithms. It received FDA 510(k) clearance on 2017-06-07 under 510(k) number K160673. 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 Insulin Algorithms System?

Insulin Algorithms System is a medical device that received FDA 510(k) clearance on 2017-06-07. The listed applicant is Insulin Algorithms. The 510(k) number is K160673.

When did Insulin Algorithms System receive FDA 510(k) clearance?

Insulin Algorithms System received FDA 510(k) clearance on 2017-06-07, under 510(k) number K160673.

Who is the listed applicant for Insulin Algorithms System?

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

What is the FDA product code for Insulin Algorithms System?

The FDA product code for Insulin Algorithms System is NDC.

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Official Source

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