K-number	K060042
Device name	LANDLEX, MODEL P100X
Applicant	Besteam Technology, Inc.
Product code	INI
Device class	Class II
Decision date	Feb 14, 2006
Decision	Substantially Equivalent
Regulation	890.3800

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 →

Building an AI or ML-enabled device? Predicate search, PCCP tracking, and AI-specific FDA intelligence — built exclusively for AI/ML devices. Try AIFDA Intel →

LANDLEX, MODEL P100X

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