VitalSigns 1-Lead Holter (VSH101)
K-Number: K243003 · 2025-06-17
ApplicantVitalSigns Technology Co., Ltd.
Decision Date2025-06-17
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
VitalSigns 1-Lead Holter (VSH101) is a medical device manufactured by VitalSigns Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-06-17 under approval number K243003. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the VitalSigns 1-Lead Holter (VSH101)?
VitalSigns 1-Lead Holter (VSH101) is a medical device that received FDA 510(k) clearance on 2025-06-17. It is manufactured by VitalSigns Technology Co., Ltd.. The 510(k) number is K243003.
When was VitalSigns 1-Lead Holter (VSH101) approved by the FDA?
VitalSigns 1-Lead Holter (VSH101) received FDA 510(k) clearance on 2025-06-17, under approval number K243003.
What company makes VitalSigns 1-Lead Holter (VSH101)?
VitalSigns 1-Lead Holter (VSH101) is manufactured by VitalSigns Technology Co., Ltd..
What is the FDA product code for VitalSigns 1-Lead Holter (VSH101)?
The FDA product code for VitalSigns 1-Lead Holter (VSH101) is DXH. This falls under the Hematology category.
Related Devices (Code: DXH)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.