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510(k) K240696

Device
Airdog X8 Air Purifier (KJ800F-X8)
Applicant
Suzhou Beiang Smart Technology Co., Ltd.
510(k) number
K240696
Product code
FRF
Decision
Substantially Equivalent (SESE)
Decision date
2024-06-14
Date received
2024-03-14
Regulation
880.5045
Classification name
Cleaner, Air, Medical Recirculating
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Special
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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