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FDA 510(k)

EOS Air Cleaner

K-Number: K202766 · 2021-06-11

ApplicantGuangzhou Ajax Medical Equipment Co., Ltd.
Decision Date2021-06-11
Product CodeFRA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EOS Air Cleaner is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Ajax Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2021-06-11 under 510(k) number K202766. 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 EOS Air Cleaner?

EOS Air Cleaner is a medical device that received FDA 510(k) clearance on 2021-06-11. The listed applicant is Guangzhou Ajax Medical Equipment Co., Ltd.. The 510(k) number is K202766.

When did EOS Air Cleaner receive FDA 510(k) clearance?

EOS Air Cleaner received FDA 510(k) clearance on 2021-06-11, under 510(k) number K202766.

Who is the listed applicant for EOS Air Cleaner?

The FDA 510(k) record lists Guangzhou Ajax Medical Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EOS Air Cleaner?

The FDA product code for EOS Air Cleaner is FRA.

Other records listing Guangzhou Ajax Medical Equipment Co., 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.

K252110Dental X-RAY Unit (AJX200)K250164Cassette Autoclave (ACA5)

Related Devices (Code: FRA)

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.

K252128Zener® (model ZEN-001-B1)Uvx, Inc.K241140ViroZap Indoor Air Purifier, In Duct Model 1008Applied Photonix, LLCK232642AirKEE T900Healkee Medical Pte, Ltd.K232933AirKEE P900Healkee Medical Pte, Ltd.K232645Airgle Room Air PurifierAirgle CorporationK221540Synexis Sphere RxSynexis, LLC

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.

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