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FDA 510(k) Application Details - K210274
Device Classification Name
Oximeter
More FDA Info for this Device
510(K) Number
K210274
Device Name
Oximeter
Applicant
Zhuhai Linte Medical Instrument Co., Ltd.
4th Floor, Building 1, No.66, Yongda Road, Hongqi Town,
Jinwan District
Zhuhai 519090 CN
Other 510(k) Applications for this Company
Contact
Kezheng Ma
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
02/01/2021
Decision Date
07/30/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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