Name: Predicase
Price: 199 USD

K-number	K111854
Device name	AO USB RECEIVER, WI-BOX, WI-BOX PSU KIT, WI-BOX XPRESS CABLE, PW USB RECEIVER
Applicant	St. Jude Medical Systems AB
Product code	DRG
Device class	Class II
Decision date	Oct 21, 2011
Decision	Substantially Equivalent
Regulation	870.2910

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 →

AO USB RECEIVER, WI-BOX, WI-BOX PSU KIT, WI-BOX XPRESS CABLE, PW USB RECEIVER

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