EOS Air Cleaner

Purifier, Air, Ultraviolet, Medical

Guangzhou Ajax Medical Equipment Co., Ltd.

The following data is part of a premarket notification filed by Guangzhou Ajax Medical Equipment Co., Ltd. with the FDA for Eos Air Cleaner.

Pre-market Notification Details

Device IDK202766
510k NumberK202766
Device Name:EOS Air Cleaner
ClassificationPurifier, Air, Ultraviolet, Medical
Applicant Guangzhou Ajax Medical Equipment Co., Ltd. Building No 2 Dagang Industrial Zone, Shilou Town,Panyu, District Guangzhou,  CN 511447
ContactAtwood Lee
CorrespondentIris Fung
SGS-CSTC Standards Technical Services Co., Ltd. 198 KEZHU Road, SCIENTECH Park Guangzhou Economic & Technology Deve Guangzhou,  CN
Product CodeFRA  
CFR Regulation Number880.6500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-21
Decision Date2021-06-11

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