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510(k) K202851

Spo2 Sensor by Jkh USA, LLC — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 2020
Date Received
September 28, 2020
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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