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FDA 510(k)

Panda iRes Warmer, Giraffe Warmer

K-Number: K201628 · 2021-02-12

ApplicantGE Healthcare
Decision Date2021-02-12
Product CodeFMT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Panda iRes Warmer, Giraffe Warmer is a medical device manufactured by GE Healthcare. It received FDA 510(k) clearance on 2021-02-12 under approval number K201628. The device is classified under product code FMT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Panda iRes Warmer, Giraffe Warmer?

Panda iRes Warmer, Giraffe Warmer is a medical device that received FDA 510(k) clearance on 2021-02-12. It is manufactured by GE Healthcare. The 510(k) number is K201628.

When was Panda iRes Warmer, Giraffe Warmer approved by the FDA?

Panda iRes Warmer, Giraffe Warmer received FDA 510(k) clearance on 2021-02-12, under approval number K201628.

What company makes Panda iRes Warmer, Giraffe Warmer?

Panda iRes Warmer, Giraffe Warmer is manufactured by GE Healthcare.

What is the FDA product code for Panda iRes Warmer, Giraffe Warmer?

The FDA product code for Panda iRes Warmer, Giraffe Warmer is FMT.

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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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