K-number	K982889
Device name	MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 1000
Applicant	Electromed, Inc.
Product code	BYI
Device class	Class II
Decision date	Jun 1, 1999
Decision	Substantially Equivalent
Regulation	868.5665

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 →

MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 1000

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