Cleared Traditional

Arm-type Fully Automatic Digital Blood Pressure Monitor

K231303 · Joytech Healthcare Co. , Ltd. · Cardiovascular
Jan 2024
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K231303 is an FDA 510(k) clearance for the Arm-type Fully Automatic Digital Blood Pressure Monitor, a System, Measurement, Blood-pressure, Non-invasive (Class II — Special Controls, product code DXN), submitted by Joytech Healthcare Co. , Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on January 26, 2024, 266 days after receiving the submission on May 5, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1130.

Submission Details

510(k) Number K231303 FDA.gov
FDA Decision Cleared SESE
Date Received May 05, 2023
Decision Date January 26, 2024
Days to Decision 266 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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