Cleared Abbreviated

Arm Blood Pressure Monitor

K222869 · Andon Health Co, Ltd. · Cardiovascular
Feb 2023
Decision
146d
Days
Class 2
Risk

About This 510(k) Submission

K222869 is an FDA 510(k) clearance for the Arm Blood Pressure Monitor, a System, Measurement, Blood-pressure, Non-invasive (Class II — Special Controls, product code DXN), submitted by Andon Health Co, Ltd. (Tianjin, CN). The FDA issued a Cleared decision on February 15, 2023, 146 days after receiving the submission on September 22, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1130.

Submission Details

510(k) Number K222869 FDA.gov
FDA Decision Cleared SESE
Date Received September 22, 2022
Decision Date February 15, 2023
Days to Decision 146 days
Submission Type Abbreviated
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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