Cleared Traditional

Upper Arm Type Blood Pressure Monitor

K220886 · Shenzhen Jamr Technology Co., Ltd. · Cardiovascular
Jul 2022
Decision
121d
Days
Class 2
Risk

About This 510(k) Submission

K220886 is an FDA 510(k) clearance for the Upper Arm Type 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 July 27, 2022, 121 days after receiving the submission on March 28, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1130.

Submission Details

510(k) Number K220886 FDA.gov
FDA Decision Cleared SESE
Date Received March 28, 2022
Decision Date July 27, 2022
Days to Decision 121 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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