K243003 is an FDA 510(k) clearance for the VitalSigns 1-Lead Holter (VSH101). This device is classified as a Transmitters And Receivers, Electrocardiograph, Telephone (Class II - Special Controls, product code DXH).
Submitted by VitalSigns Technology Co., Ltd. (Hsinchu County, TW). The FDA issued a Cleared decision on June 17, 2025, 264 days after receiving the submission on September 26, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2920.
| 510(k) Number | K243003 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 2024 |
| Decision Date | June 17, 2025 |
| Days to Decision | 264 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXH - Transmitters And Receivers, Electrocardiograph, Telephone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2920 |