VitalSigns 1-Lead Holter (VSH101)— 510(k) K243003
Substantially EquivalentVitalSigns 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.. Device class: 2.
Clearance details
- Applicant
- VitalSigns Technology Co., Ltd.
- Product code
- Code DXH
- Device class
- Class 2
- Regulation
- 21 CFR 870.2920
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hsinchu County, TW
Recent devices under product code DXH
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