Device Classification Name |
Cleaner, Air, Medical Recirculating
|
510(k) Number |
K211507 |
Device Name |
Airdog X5 Recirculating Air Cleaner (model KJ300F-X5) |
Applicant |
Beiang Air Tech LTD. |
175#, Songbei Road, Suzhou Industrial Park |
Suzhou,
CN
215000
|
|
Applicant Contact |
Yan Zhang |
Correspondent |
Medical Wizdom, LLC |
12F.-4, No. 81, Sec. 2, Chang'an E. Rd., Zhongshan Dist. |
Taipei,
TW
10491
|
|
Correspondent Contact |
Tyra Chiu |
Regulation Number | 880.5045
|
Classification Product Code |
|
Date Received | 05/14/2021 |
Decision Date | 11/22/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|