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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is VitalSigns Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-06-17 under 510(k) 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. The listed applicant is VitalSigns Technology Co., Ltd.. The 510(k) number is K243003.

When did VitalSigns 1-Lead Holter (VSH101) receive FDA 510(k) clearance?

VitalSigns 1-Lead Holter (VSH101) received FDA 510(k) clearance on 2025-06-17, under 510(k) number K243003.

Who is the listed applicant for VitalSigns 1-Lead Holter (VSH101)?

The FDA 510(k) record lists VitalSigns Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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