510(k) K243003— VitalSigns 1-Lead Holter (VSH101)

Substantially Equivalent

VitalSigns Technology Co., Ltd.

Clearance details

Applicant: VitalSigns Technology Co., Ltd.
Product code: Code DXH
Advisory panel: Cardiovascular
Date received: 2024-09-26
Decision date: 2025-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsinchu County, TW

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.