510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN240074Unknown

Pulsenmore ES

Pulsenmore Ltd, Omer, IL / Direct, Unknown
FDA source (opens on fda.gov)

DEN240074 is the FDA 510(k) clearance record for Pulsenmore ES, a class II device, cleared for Pulsenmore, Ltd. on under FDA product code SGJ (Ultrasound Imaging System For Acquiring Images At Home By Lay Users). FDA's definition for product code SGJ reads: "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...". FDA records list one 510(k) clearance for Pulsenmore, Ltd. As of , FDA records show no recalls naming DEN240074.

Clearance record

Decision date
Received
(324 days to decision)
Product code
SGJ Ultrasound Imaging System For Acquiring Images At Home By Lay Users
Regulation
21 CFR 892.1590
Device class
Class II
Review panel
Radiology
Applicant
Pulsenmore, Ltd. 8 Omarim St., Omer, IL
Third party review
No

Clearances, product code SGJ

Trailing 12 months

FDA records hold no clearances under product code SGJ in the trailing twelve months.

FDA records show no clearances under product code SGJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code SGJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260