K-numberK060475
Device nameEVIS EXERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE, OLYMPUS MODEL BF TYPE UC160F-OL8
ApplicantOlympus Medical Systems Corporation
Product codeODB
Device classClass II
Decision dateMar 17, 2006
DecisionSubstantially Equivalent
Regulation876.1500
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 →

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

14-day free trial. No setup. Cancel anytime.

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 →