Name: Predicase
Price: 199 USD

K-number	K252412
Device name	Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator)
Applicant	Applied Medical Resources Corporation
Product code	GEI
Device class	Class II
Decision date	Oct 31, 2025
Decision	Substantially Equivalent
Regulation	878.4400

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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Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator)

Everything you need for a 510(k) submission. Nothing you don't.