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510(k) K192608

Disposable SpO2 Sensor by Shenzhen Sino-K Medical Technology Co.,Ltd — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 2020
Date Received
September 20, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oximeter
Device Class
Class II
Regulation Number
870.2700
Review Panel
AN
Submission Type

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