Name: Predicase
Price: 199 USD

K-number	K232529
Device name	Disposable Double Lumen Endobronchial Tube
Applicant	Shenzhen Insighters Medical Technology Co., Ltd.
Product code	CBI
Device class	Class II
Decision date	May 13, 2024
Decision	Substantially Equivalent
Regulation	868.5740

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 →

Disposable Double Lumen Endobronchial Tube

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