Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

AirKEE P900

K-Number: K232933 · 2024-05-16

ApplicantHealkee Medical Pte, Ltd.
Decision Date2024-05-16
Product CodeFRA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AirKEE P900 is a medical device manufactured by Healkee Medical Pte, Ltd.. It received FDA 510(k) clearance on 2024-05-16 under approval number K232933. 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 P900?

AirKEE P900 is a medical device that received FDA 510(k) clearance on 2024-05-16. It is manufactured by Healkee Medical Pte, Ltd.. The 510(k) number is K232933.

When was AirKEE P900 approved by the FDA?

AirKEE P900 received FDA 510(k) clearance on 2024-05-16, under approval number K232933.

What company makes AirKEE P900?

AirKEE P900 is manufactured by Healkee Medical Pte, Ltd..

What is the FDA product code for AirKEE P900?

The FDA product code for AirKEE P900 is FRA.

Other Devices by Healkee Medical Pte, Ltd.

K232642AirKEE T900

Related Devices (Code: FRA)

K161468Transformair Indoor Air PurifierTransformair, LLC K201220Aerus Medical Guardian,model F170AAerus Medical, LLC K200500Molekule Air Pro RXMolekule, Inc. K211139CUBE Air PurifierSamsung Electronics Co., Ltd. K211194Molekule Air ProMolekule, Inc. K202766EOS Air CleanerGuangzhou Ajax Medical Equipment Co., Ltd.

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.

↑