VitalSigns 1-Lead Holter (VSH101)
FDA 510(k) K243003 · VitalSigns Technology Co., Ltd.
510(k) numberK243003
Submission
- Device name
- VitalSigns 1-Lead Holter (VSH101)
- Applicant
- VitalSigns Technology Co., Ltd.
Hsinchu County, TW - Received
- September 26, 2024
- Decision date
- June 17, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXH – Transmitters And Receivers, Electrocardiograph, Telephone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2920
- Specialty
- Cardiovascular
Other 510(k)s with product code DXH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250233 | PreemptiveAI Clinical SDKDXH · Traditional | Measure Labs, Inc. (Dba Preemptiveai, Inc.) | 02/13/2026SE |
| K250258 | HeartBeam AIMIGo with 12-L ECG Synthesis Software SystemDXH · Traditional | Heartbeam, Inc. | 12/08/2025SE |
| K243438 | MEMO Patch M (MPT-E08R-UNC01)DXH · Traditional | Huinno Co., Ltd. | 12/05/2025SE |
| K243981 | Hexoskin Medical System (7100-00016)DXH · Traditional | Carre Technologies, Inc. | 11/18/2025SE |
| K233521 | QT ECG (QTERD100)DXH · Special | QT Medical, Inc. | 12/06/2023SE |
| K222842 | V-Patch Cardiac MonitorDXH · Traditional | Shandong Corecare Technology Limited | 10/20/2022SE |
| K220795 | QT ECGDXH · Traditional | QT Medical, Inc. | 09/26/2022SE |
| K213357 | Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse MonitorDXH · Traditional | Verily Life Sciences, LLC | 07/19/2022SE |
| K220350 | KardiaMobile 6LDXH · Traditional | AliveCor, Inc. | 05/25/2022SE |
| K211668 | KardiaMobile CardDXH · Special | AliveCor, Inc. | 11/30/2021SE |
Questions and answers
When was VitalSigns 1-Lead Holter (VSH101) cleared by the FDA?
VitalSigns 1-Lead Holter (VSH101) (K243003) received a 510(k) decision of Substantially Equivalent on June 17, 2025, 264 days after the submission was received.
What is the product code of K243003?
The FDA product code is DXH – Transmitters And Receivers, Electrocardiograph, Telephone, a Class II (moderate risk) device regulated under 21 CFR 870.2920.