Name: Predicase
Price: 199 USD

K-number	K140899
Device name	HALO MEDICAL TECHNOLOGIES CATALYST MIDCRYSTL HALO ULTRASOUND SYSTEM
Applicant	Halo Medical Technologies, LLC
Product code	IYO
Device class	Class II
Decision date	May 5, 2014
Decision	Substantially Equivalent
Regulation	892.1560

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 →

HALO MEDICAL TECHNOLOGIES CATALYST MIDCRYSTL HALO ULTRASOUND SYSTEM

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