Name: Predicase
Price: 199 USD

K-number	K252740
Device name	Voyant® Open Fusion Device (EB240/Open Fusion)
Applicant	Applied Medical Resources Corp.
Product code	GEI
Device class	Class II
Decision date	Nov 4, 2025
Decision	Substantially Equivalent
Regulation	—

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® Open Fusion Device (EB240/Open Fusion)

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