510(k) DEN240074
DEN240074 is an FDA 510(k) premarket notification submitted by Pulsenmore, Ltd. for the device "Pulsenmore ES". The FDA issued a decision of De Novo Granted on Oct 31, 2025. The device falls under product code SGJ (Ultrasound Imaging System For Acquiring Images At Home By Lay Users), a Class II device regulated under 21 CFR 892.1590.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- Oct 31, 2025
- Date Received
- Dec 11, 2024
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ultrasound Imaging System For Acquiring Images At Home By Lay Users
- Device Class
- Class II
- Regulation Number
- 892.1590
- Review Panel
- RA
- Submission Type
An ultrasound imaging system for acquiring images at home by lay users is a prescription home use device that may consist of hardware and/or software intended for acquiring ultrasound images for interpretation by a qualified health care professional (e.g., fetal images for determination of fetal heart rate). The device provides guidance to lay users to aid image acquisition.