Cleared Traditional

Clinical Automatic Blood Pressure Monitor (DBP-01P,DBP-01HP)

K231984 · Shenzhen Hingmed Medical Instrument Co., Ltd. · Cardiovascular
Mar 2024
Decision
265d
Days
Class 2
Risk

About This 510(k) Submission

K231984 is an FDA 510(k) clearance for the Clinical Automatic Blood Pressure Monitor (DBP-01P,DBP-01HP), a System, Measurement, Blood-pressure, Non-invasive (Class II — Special Controls, product code DXN), submitted by Shenzhen Hingmed Medical Instrument Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on March 26, 2024, 265 days after receiving the submission on July 5, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1130.

Submission Details

510(k) Number K231984 FDA.gov
FDA Decision Cleared SESE
Date Received July 05, 2023
Decision Date March 26, 2024
Days to Decision 265 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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