Name: Predicase
Price: 199 USD

K-number	K170463
Device name	KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System
Applicant	I-Sens, Inc.
Product code	JIN
Device class	Class I
Decision date	Apr 13, 2018
Decision	Substantially Equivalent
Regulation	862.1435

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 →

KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System

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