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FDA 510(k) Application Details - K211139
Device Classification Name
Purifier, Air, Ultraviolet, Medical
More FDA Info for this Device
510(K) Number
K211139
Device Name
Purifier, Air, Ultraviolet, Medical
Applicant
Samsung Electronics Co., Ltd.
129, Samsung-Ro, Yeongtong-Gu
Suwon-Si 16677 KR
Other 510(k) Applications for this Company
Contact
Hana Jung
Other 510(k) Applications for this Contact
Regulation Number
880.6500
More FDA Info for this Regulation Number
Classification Product Code
FRA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/16/2021
Decision Date
11/26/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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