Name: Predicase
Price: 199 USD

K-number	K092847
Device name	840 VENTILATOR SYSTEM WITH EXPANDED NEOMODE OPTION
Applicant	Covidien, Formerly Nellcor Puritan Bennett, Inc.
Product code	CBK
Device class	Class II
Decision date	Mar 11, 2010
Decision	Substantially Equivalent
Regulation	868.5895

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 →

840 VENTILATOR SYSTEM WITH EXPANDED NEOMODE OPTION

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