510(k) DEN240074

Pulsenmore ES by Pulsenmore, Ltd. — Product Code SGJ

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: October 31, 2025
Date Received: December 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.