Name: Predicase
Price: 199 USD

K-number	K233649
Device name	ALGO Pro Newborn Hearing Screener (ALGO Pro)
Applicant	Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
Product code	GWJ
Device class	Class II
Decision date	Mar 8, 2024
Decision	Substantially Equivalent
Regulation	882.1900

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 →

ALGO Pro Newborn Hearing Screener (ALGO Pro)

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