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FDA 510(k)

firefly T-2

K-Number: K201131 · 2020-05-28

ApplicantFirstkind Limited
Decision Date2020-05-28
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

firefly T-2 is the device name listed in this FDA 510(k) record. The listed applicant is Firstkind Limited. It received FDA 510(k) clearance on 2020-05-28 under 510(k) number K201131. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the firefly T-2?

firefly T-2 is a medical device that received FDA 510(k) clearance on 2020-05-28. The listed applicant is Firstkind Limited. The 510(k) number is K201131.

When did firefly T-2 receive FDA 510(k) clearance?

firefly T-2 received FDA 510(k) clearance on 2020-05-28, under 510(k) number K201131.

Who is the listed applicant for firefly T-2?

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

What is the FDA product code for firefly T-2?

The FDA product code for firefly T-2 is NGX.

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Related Devices (Code: NGX)

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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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