Name: Predicase
Price: 199 USD

K-number	K160365
Device name	BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System
Applicant	Infopia Co, Ltd.
Product code	NBW
Device class	Class II
Decision date	Sep 28, 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 →

BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System

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