Cleared Traditional

Arm Type Blood Pressure Monitor (BPM82)

K242193 · Avita Corporation · Cardiovascular
Oct 2024
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K242193 is an FDA 510(k) clearance for the Arm Type Blood Pressure Monitor (BPM82), a System, Measurement, Blood-pressure, Non-invasive (Class II — Special Controls, product code DXN), submitted by Avita Corporation (New Taipei, TW). The FDA issued a Cleared decision on October 22, 2024, 88 days after receiving the submission on July 26, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1130.

Submission Details

510(k) Number K242193 FDA.gov
FDA Decision Cleared SESE
Date Received July 26, 2024
Decision Date October 22, 2024
Days to Decision 88 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DXN — System, Measurement, Blood-pressure, Non-invasive
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1130

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