Name: Predicase
Price: 199 USD

K-number	K233555
Device name	AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask
Applicant	Philips Respironics
Product code	BZD
Device class	Class II
Decision date	Jul 31, 2024
Decision	Substantially Equivalent
Regulation	868.5905

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 →

AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask

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