Cleared Traditional

Arm Blood Pressure Monitor (model: BPM-A7VL)

K243118 · Shenzhen Imdk Medical Technology Co., Ltd. · Cardiovascular
Nov 2024
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K243118 is an FDA 510(k) clearance for the Arm Blood Pressure Monitor (model: BPM-A7VL), a System, Measurement, Blood-pressure, Non-invasive (Class II — Special Controls, product code DXN), submitted by Shenzhen Imdk Medical Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on November 26, 2024, 57 days after receiving the submission on September 30, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1130.

Submission Details

510(k) Number K243118 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2024
Decision Date November 26, 2024
Days to Decision 57 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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