The following data is part of a premarket notification filed by Guangzhou Ajax Medical Equipment Co., Ltd. with the FDA for Eos Air Cleaner.
Device ID | K202766 |
510k Number | K202766 |
Device Name: | EOS Air Cleaner |
Classification | Purifier, Air, Ultraviolet, Medical |
Applicant | Guangzhou Ajax Medical Equipment Co., Ltd. Building No 2 Dagang Industrial Zone, Shilou Town,Panyu, District Guangzhou, CN 511447 |
Contact | Atwood Lee |
Correspondent | Iris Fung SGS-CSTC Standards Technical Services Co., Ltd. 198 KEZHU Road, SCIENTECH Park Guangzhou Economic & Technology Deve Guangzhou, CN |
Product Code | FRA |
CFR Regulation Number | 880.6500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-09-21 |
Decision Date | 2021-06-11 |