Name: Predicase
Price: 199 USD

K-number	K121379
Device name	PNEUTON MINI VENTILATOR PNEUTON MINI NON-INVASIVE VENTILATION (NIV) KIT ACCESSORY
Applicant	Airon Corporation
Product code	CBK
Device class	Class II
Decision date	Oct 11, 2012
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 →

PNEUTON MINI VENTILATOR PNEUTON MINI NON-INVASIVE VENTILATION (NIV) KIT ACCESSORY

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