510(k) DEN240074
- Device
- Pulsenmore ES
- Applicant
- Pulsenmore, Ltd.
- 510(k) number
- DEN240074
- Product code
- SGJ
- Decision
- Unknown (DENG)
- Decision date
- 2025-10-31
- Date received
- 2024-12-11
- Regulation
- 892.1590
- Classification name
- Ultrasound Imaging System For Acquiring Images At Home By Lay Users
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Israel Citron
- Address
- 8 Omarim St. Omer IL 8496500 8496500
FDA Registration Numbers
- 3020542149
Source Documents
510(k) summary PDF not indicated by FDA
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07290018579053 | Pulsenmore ES Tera | PULSENMORE LTD | 2026-02-16 |
| 07290018579039 | Pulsenmore ES Type iOS | PULSENMORE LTD | 2025-11-25 |
| 07290018579008 | Pulsenmore ES Type C | PULSENMORE LTD | 2025-11-25 |