K243003
- 510(k) number
- K243003
- Device name
- VitalSigns 1-Lead Holter (VSH101)
- Applicant
- VitalSigns Technology Co., Ltd. TW
- Product code
- DXH — Transmitters And Receivers, Electrocardiograph, Tele
- Decision date
- 2025-06-17
- Date received
- 2024-09-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K243003.pdf
Official FDA record: K243003
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.