Name: Predicase
Price: 199 USD

K-number	K221836
Device name	Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus
Applicant	Drägerwerk AG & Co. KGaA
Product code	CAH
Device class	Class II
Decision date	Dec 7, 2022
Decision	Substantially Equivalent
Regulation	868.5260

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 →

Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus

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