Name: Predicase
Price: 199 USD

K-number	DEN150037
Device name	ImPACT Computerized Neurocognitive Concussion Management Aid
Applicant	Impact Applications, Inc.
Product code	POM
Device class	Class II
Decision date	Aug 22, 2016
Decision	Not Substantially Equivalent
Regulation	882.1471

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 →

ImPACT Computerized Neurocognitive Concussion Management Aid

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