Name: Predicase
Price: 199 USD

K-number	K844051
Device name	SKILCRAFT - TRACHEOTOMY CARE KIT 3 COMPARTMENT
Applicant	Washington-Greene County Branch Pennsylvania Assoc
Product code	NXA
Device class	Class II
Decision date	Jan 18, 1985
Decision	Substantially Equivalent
Regulation	868.5800

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 →

SKILCRAFT - TRACHEOTOMY CARE KIT 3 COMPARTMENT

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