Name: Predicase
Price: 199 USD

K-number	K190560
Device name	SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface
Applicant	Nonin Medical, Inc.
Product code	MUD
Device class	Class II
Decision date	May 2, 2019
Decision	Substantially Equivalent
Regulation	870.2700

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 →

SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface

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