Cleared Traditional

Blood Pressure Monitor

K233146 · Shenzhen Jamr Technology Co., Ltd. · Cardiovascular
Mar 2024
Decision
174d
Days
Class 2
Risk

About This 510(k) Submission

K233146 is an FDA 510(k) clearance for the Blood Pressure Monitor, a System, Measurement, Blood-pressure, Non-invasive (Class II — Special Controls, product code DXN), submitted by Shenzhen Jamr Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on March 19, 2024, 174 days after receiving the submission on September 27, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1130.

Submission Details

510(k) Number K233146 FDA.gov
FDA Decision Cleared SESE
Date Received September 27, 2023
Decision Date March 19, 2024
Days to Decision 174 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement

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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