FDA 510(k)

AirKEE T900

K-Number: K232642 · 2024-05-23

Decision Date2024-05-23

Product CodeFRA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

AirKEE T900 is the device name listed in this FDA 510(k) record. The listed applicant is Healkee Medical Pte, Ltd.. It received FDA 510(k) clearance on 2024-05-23 under 510(k) number K232642. The device is classified under product code FRA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AirKEE T900?

AirKEE T900 is a medical device that received FDA 510(k) clearance on 2024-05-23. The listed applicant is Healkee Medical Pte, Ltd.. The 510(k) number is K232642.

When did AirKEE T900 receive FDA 510(k) clearance?

AirKEE T900 received FDA 510(k) clearance on 2024-05-23, under 510(k) number K232642.

Who is the listed applicant for AirKEE T900?

The FDA 510(k) record lists Healkee Medical Pte, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AirKEE T900?

The FDA product code for AirKEE T900 is FRA.

Other records listing Healkee Medical Pte, Ltd. 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.

K232933AirKEE P900

Related Devices (Code: FRA)

K252128Zener® (model ZEN-001-B1)Uvx, Inc.K241140ViroZap Indoor Air Purifier, In Duct Model 1008Applied Photonix, LLC K232933AirKEE P900Healkee Medical Pte, Ltd.K232645Airgle Room Air PurifierAirgle Corporation K221540Synexis Sphere RxSynexis, LLC K222702RGS; RGS MiniGenesis Air, Inc.

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.