Name: Predicase
Price: 199 USD

K-number	K946318
Device name	MODEL 1001, HYDRODOT(TM) NEUROMONITORING SYSTEM WITH E NET(TM) EEG INTERFACE CABLE
Applicant	Physiometrix, Inc.
Product code	GXY
Device class	Class II
Decision date	Apr 24, 1995
Decision	Substantially Equivalent
Regulation	882.1320

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 →

MODEL 1001, HYDRODOT(TM) NEUROMONITORING SYSTEM WITH E NET(TM) EEG INTERFACE CABLE

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