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FDA 510(k) Application Details - K221979
Device Classification Name
Oximeter
More FDA Info for this Device
510(K) Number
K221979
Device Name
Oximeter
Applicant
Shenzhen IMDK Medical Technology CO., Ltd.
C Zone 10F, Building 16, Yuanshan Industrial B Area,
Gongming Street, Guangming District
Shenzhen 518106 CN
Other 510(k) Applications for this Company
Contact
Yuan Xia
Other 510(k) Applications for this Contact
Regulation Number
870.2700
More FDA Info for this Regulation Number
Classification Product Code
DQA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/05/2022
Decision Date
10/16/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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