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FDA 510(k)

geko W-2

K-Number: K212762 · 2021-11-29

ApplicantFirstkind Limited
Decision Date2021-11-29
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

geko W-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 2021-11-29 under 510(k) number K212762. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the geko W-2?

geko W-2 is a medical device that received FDA 510(k) clearance on 2021-11-29. The listed applicant is Firstkind Limited. The 510(k) number is K212762.

When did geko W-2 receive FDA 510(k) clearance?

geko W-2 received FDA 510(k) clearance on 2021-11-29, under 510(k) number K212762.

Who is the listed applicant for geko W-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 geko W-2?

The FDA product code for geko W-2 is IPF.

Other records listing Firstkind Limited 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.

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Related Devices (Code: IPF)

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.

K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.K252816High Tone Power therapy (HiToP) (Model: HiToP PNP)Mohammadali NezakatiK260142StimelMD (SSMD) systemMotion Informatics ltd.K251083Compact IIEnraf-Nonius, B.V.K241433EVE Synergy (EVE-20M)Weero Co., Ltd.K241488TrainFES AdvanceTrainfes

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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