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510(k) K172141

Pulse Oximeter by Shanghai Berry Electronic Tech Co., Ltd. — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 2018
Date Received
July 17, 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

Other clearances by Shanghai Berry Electronic Tech Co., Ltd.

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  • K142687 — Pulse Oximeter (April 13, 2015)

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  • K251695 — Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Senso (November 18, 2025)
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