Cleared Traditional

Blood Pressure Monitor (BBZ32-AA01)

K240832 · Guangdong Transtek Medical Electronics Co., Ltd. · Cardiovascular
Jun 2024
Decision
73d
Days
Class 2
Risk

About This 510(k) Submission

K240832 is an FDA 510(k) clearance for the Blood Pressure Monitor (BBZ32-AA01), 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 June 7, 2024, 73 days after receiving the submission on March 26, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1130.

Submission Details

510(k) Number K240832 FDA.gov
FDA Decision Cleared SESE
Date Received March 26, 2024
Decision Date June 07, 2024
Days to Decision 73 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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