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510(k) K232495

Sempulse Halo Vital Signs Monitor by Sempulse Corporation — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 2024
Date Received
August 17, 2023
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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