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
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