Cleared Traditional

VitalSigns 1-Lead Holter (VSH101)

K243003 · VitalSigns Technology Co., Ltd. · Cardiovascular

Jun 2025

Decision

264d

Days

Class 2

Risk

About This 510(k) Submission

K243003 is an FDA 510(k) clearance for the VitalSigns 1-Lead Holter (VSH101), a Transmitters And Receivers, Electrocardiograph, Telephone (Class II — Special Controls, product code DXH), submitted by VitalSigns Technology Co., Ltd. (Hsinchu County, TW). The FDA issued a Cleared decision on June 17, 2025, 264 days after receiving the submission on September 26, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2920.

Submission Details

510(k) Number	K243003 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 26, 2024
Decision Date	June 17, 2025
Days to Decision	264 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF