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510(k) K201360

Reusable and Disposable SpO2 Sensors by Xinkang Medical Instrument Co. , Ltd. — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 2020
Date Received
May 21, 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

Other clearances by Xinkang Medical Instrument Co. , Ltd.

  • K201359 — ECG Cables and Leadwires (October 1, 2020)

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