Name: Predicase
Price: 199 USD

K-number	K161738
Device name	FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring Systems
Applicant	Taidoc Technology Corporation
Product code	NBW
Device class	Class II
Decision date	Nov 10, 2016
Decision	Substantially Equivalent
Regulation	862.1345

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 →

FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring Systems

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