Cleared Traditional

Wrist Type Blood Pressure Monitor (W05,W1101L)

K230409 · Shenzhen Jamr Technology Co., Ltd. · Cardiovascular
Aug 2023
Decision
191d
Days
Class 2
Risk

About This 510(k) Submission

K230409 is an FDA 510(k) clearance for the Wrist Type Blood Pressure Monitor (W05,W1101L), 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 August 25, 2023, 191 days after receiving the submission on February 15, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1130.

Submission Details

510(k) Number K230409 FDA.gov
FDA Decision Cleared SESE
Date Received February 15, 2023
Decision Date August 25, 2023
Days to Decision 191 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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