DEN240074
- 510(k) number
- DEN240074
- Device name
- Pulsenmore ES
- Applicant
- Pulsenmore, Ltd. IL
- Product code
- SGJ — Ultrasound Imaging System For Acquiring Images At Ho
- Decision date
- 2025-10-31
- Date received
- 2024-12-11
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Radiology
Official FDA record: DEN240074
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.