Name: Predicase
Price: 199 USD

K-number	K041412
Device name	ESPRIT VENTILATOR WITH NICO-ESPRIT INTERFACE OPTION, MODEL V1000
Applicant	Respironics California, Inc.
Product code	CBK
Device class	Class II
Decision date	Jun 18, 2004
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 →

ESPRIT VENTILATOR WITH NICO-ESPRIT INTERFACE OPTION, MODEL V1000

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