K-number	K250501
Device name	System Sophi
Applicant	This AG
Product code	HQC
Device class	Class II
Decision date	Nov 14, 2025
Decision	Substantially Equivalent
Regulation	886.4670

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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System Sophi

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