Cleared Traditional

Blood Pressure Monitor

K200437 · Shenzhen Jamr Technology Co., Ltd. · Cardiovascular
Jun 2020
Decision
122d
Days
Class 2
Risk

About This 510(k) Submission

K200437 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 June 25, 2020, 122 days after receiving the submission on February 24, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1130.

Submission Details

510(k) Number K200437 FDA.gov
FDA Decision Cleared SESE
Date Received February 24, 2020
Decision Date June 25, 2020
Days to Decision 122 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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