Cleared Special

Blood Pressure Monitor (TMB-2092-G)

K241351 · Guangdong Transtek Medical Electronics Co., Ltd. · Cardiovascular
Aug 2024
Decision
100d
Days
Class 2
Risk

About This 510(k) Submission

K241351 is an FDA 510(k) clearance for the Blood Pressure Monitor (TMB-2092-G), 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 August 21, 2024, 100 days after receiving the submission on May 13, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1130.

Submission Details

510(k) Number K241351 FDA.gov
FDA Decision Cleared SESE
Date Received May 13, 2024
Decision Date August 21, 2024
Days to Decision 100 days
Submission Type Special
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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