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510(k) K253152

BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000) by Biozen, LLC — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 2026
Date Received
September 26, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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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