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510(k) K211507

Device
Airdog X5 Recirculating Air Cleaner (model KJ300F-X5)
Applicant
Beiang Air Tech , Ltd.
510(k) number
K211507
Product code
FRF
Decision
Substantially Equivalent (SESE)
Decision date
2022-11-22
Date received
2021-05-14
Regulation
880.5045
Classification name
Cleaner, Air, Medical Recirculating
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Yan Zhang
Address
175#, Songbei Rd., Suzhou Industrial Park Suzhou CN 215000 215000

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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