Name: Predicase
Price: 199 USD

K-number	K143104
Device name	Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-X
Applicant	Kettenbach GmbH & Co. KG
Product code	EBF
Device class	Class II
Decision date	Mar 25, 2015
Decision	Substantially Equivalent
Regulation	872.3690

AI Summary

AI extraction for this record is queued and will appear within 24 hours. View full FDA record →

Source

View the full FDA submission: accessdata.fda.gov

Researching this as a predicate?

Want a transparent AI-ranking score, AI-discovered related predicates, ongoing safety and warning-letter monitoring, full predicate chain lineage, and a drafted SE rationale — all saved to your own project? That's what an account adds.

Start free trial →

Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-X

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