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510(k) K172981

Reusable SpO2 Sensors, Disposable SpO2 Sensors by APK Technology Co., Ltd. — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 2018
Date Received
September 27, 2017
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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