K-number	DEN240074
Device name	Pulsenmore ES
Applicant	Pulsenmore, Ltd.
Product code	SGJ
Device class	Class II
Decision date	Oct 31, 2025
Decision	Not Substantially Equivalent
Regulation	892.1590

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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Pulsenmore ES

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