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510(k) K250091

KOROT Blood Pressure Monitor (KOROT P3 Accurate) by Korot Co., Ltd. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2025
Date Received
January 14, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Device Class
Class II
Regulation Number
870.1130
Review Panel
CV
Submission Type

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