Name: Predicase
Price: 199 USD

K-number	K052412
Device name	INNOVA 2100-IQ, INNOVA 3100, INNOVA 3100-IQ, INNOVA 4100, AND INNOVA 4100-IQ
Applicant	GE Healthcare
Product code	OWB
Device class	Class II
Decision date	Sep 16, 2005
Decision	Substantially Equivalent
Regulation	892.1650

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 →

INNOVA 2100-IQ, INNOVA 3100, INNOVA 3100-IQ, INNOVA 4100, AND INNOVA 4100-IQ

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