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510(k) K152091

Fingertip Pulse Oximeter by Jiangsu Konsung Bio-Medical Science & Technology Co., Ltd. — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 2016
Date Received
July 27, 2015
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 Jiangsu Konsung Bio-Medical Science & Technology Co., Ltd.

  • K223740 — Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5) (October 5, 2023)
  • K152089 — Wrist Pulse Oximeter (August 17, 2016)

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