FDA 510(k)

firefly T-2

K-Number: K201131 · 2020-05-28

Decision Date2020-05-28

Product CodeNGX

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

firefly T-2 is a medical device manufactured by Firstkind Limited. It received FDA 510(k) clearance on 2020-05-28 under approval 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. It is manufactured by Firstkind Limited. The 510(k) number is K201131.

When was firefly T-2 approved by the FDA?

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

What company makes firefly T-2?

firefly T-2 is manufactured by Firstkind Limited.

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

The FDA product code for firefly T-2 is 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.