Name: Predicase
Price: 199 USD

K-number	K130417
Device name	AUDIFON SUENO CIC, AUDIFON SUENO S, AUDIFON SUENO T CIC, AUDIFON SUENO T S
Applicant	Audifon-USA, Inc.
Product code	KLW
Device class	Class II
Decision date	Sep 12, 2013
Decision	Substantially Equivalent
Regulation	874.3400

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 →

AUDIFON SUENO CIC, AUDIFON SUENO S, AUDIFON SUENO T CIC, AUDIFON SUENO T S

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