K-number	K011534
Device name	EEG MIS MONITOR MODEL # A-2000; BIS ENGINE
Applicant	Aspect Medical Systems, Inc.
Product code	OLW
Device class	Class II
Decision date	Jun 15, 2001
Decision	Substantially Equivalent
Regulation	882.1400

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 →

EEG MIS MONITOR MODEL # A-2000; BIS ENGINE

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