Cleared Traditional

Blood Pressure Monitor (TMB-2287-B)

K240102 · Guangdong Transtek Medical Electronics Co., Ltd. · Cardiovascular
Apr 2024
Decision
104d
Days
Class 2
Risk

About This 510(k) Submission

K240102 is an FDA 510(k) clearance for the Blood Pressure Monitor (TMB-2287-B), a System, Measurement, Blood-pressure, Non-invasive (Class II — Special Controls, product code DXN), submitted by Guangdong Transtek Medical Electronics Co., Ltd. (Zhongshan, CN). The FDA issued a Cleared decision on April 29, 2024, 104 days after receiving the submission on January 16, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1130.

Submission Details

510(k) Number K240102 FDA.gov
FDA Decision Cleared SESE
Date Received January 16, 2024
Decision Date April 29, 2024
Days to Decision 104 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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