Cleared Traditional

Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62D0L, DBP-62D0B, DBP-61D0, DBP-61D0L, DBP-6293L, DBP-6293B, DBP-6193)

K241431 · Joytech Healthcare Co. , Ltd. · Cardiovascular
Jan 2025
Decision
237d
Days
Class 2
Risk

About This 510(k) Submission

K241431 is an FDA 510(k) clearance for the Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62D0L, DBP-62D0B, DBP-61D0, DBP-61D0L, DBP-6293L, DBP-6293B, DBP-6193), 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 13, 2025, 237 days after receiving the submission on May 21, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1130.

Submission Details

510(k) Number K241431 FDA.gov
FDA Decision Cleared SESE
Date Received May 21, 2024
Decision Date January 13, 2025
Days to Decision 237 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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