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FDA 510(k) Application Details - K240696
Device Classification Name
Cleaner, Air, Medical Recirculating
More FDA Info for this Device
510(K) Number
K240696
Device Name
Cleaner, Air, Medical Recirculating
Applicant
Suzhou Beiang Smart Technology Co., Ltd.
175#, Songbei Road, Suzhou Industrial Park
Suzhou 215000 CN
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Contact
Yan Zhang
Other 510(k) Applications for this Contact
Regulation Number
880.5045
More FDA Info for this Regulation Number
Classification Product Code
FRF
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More FDA Info for this Product Code
Date Received
03/14/2024
Decision Date
06/14/2024
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K240696
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