K-number	K040068
Device name	BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM
Applicant	Ohmeda Medical
Product code	FMZ
Device class	Class II
Decision date	Apr 16, 2004
Decision	Substantially Equivalent
Regulation	880.5400

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 →

BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM

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