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510(k) K200346

Wrist Type Blood Pressure Monitor by Avita Corporation — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2020
Date Received
February 11, 2020
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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  • K112825 — AVITA ARM TYPE BLOOD PRESSURE MONITOR (January 18, 2012)
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Other clearances for product code DXN

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  • K253133 — Wrist Blood Pressure Monitor (BPM-W1VL) (February 13, 2026)
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  • K251143 — Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L) (December 19, 2025)
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