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

Substantially Equivalent

VitalSigns Technology Co., Ltd.

FDA 510(k) clearance K243003 for VitalSigns 1-Lead Holter (VSH101), Substantially Equivalent on 2025-06-17. Applicant: 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

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