Name: Predicase
Price: 199 USD

K-number	K143359
Device name	CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector
Applicant	Lifewatch Technologies , Ltd.
Product code	DSI
Device class	Class II
Decision date	Sep 11, 2015
Decision	Substantially Equivalent
Regulation	870.1025

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 →

CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector

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