Clearance Summary
Pulsenmore ES received FDA 510(k) clearance under submission number DEN240074, sponsored by Pulsenmore, Ltd.. The device was reviewed via the Direct premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2025-10-31.
- Submission: DEN240074
- Applicant / Sponsor: Pulsenmore, Ltd.
- Clearance pathway: Direct
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1590
- Decision date: 2025-10-31
Classification & Regulation
This clearance is catalogued under FDA product code SGJ and 21 CFR 892.1590, within the Radiology review panel as a Class II device.