K-number	DEN200041
Device name	Comfort Marker 2.0.
Applicant	Medical Precision BV
Product code	QRN
Device class	Class II
Decision date	Dec 10, 2021
Decision	Not Substantially Equivalent
Regulation	892.5785

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 →

Building an AI or ML-enabled device? Predicate search, PCCP tracking, and AI-specific FDA intelligence — built exclusively for AI/ML devices. Try AIFDA Intel →

Comfort Marker 2.0.

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