510(k) K243003
K243003 is an FDA 510(k) premarket notification submitted by VitalSigns Technology Co., Ltd. for the device "VitalSigns 1-Lead Holter (VSH101)". The FDA issued a decision of Substantially Equivalent on June 17, 2025. The device falls under product code DXH (Transmitters And Receivers, Electrocardiograph, Telephone), a Class II device regulated under 21 CFR 870.2920.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 17, 2025
- Date Received
- September 26, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transmitters And Receivers, Electrocardiograph, Telephone
- Device Class
- Class II
- Regulation Number
- 870.2920
- Review Panel
- CV
- Submission Type