Name: Predicase
Price: 199 USD

K-number	K151781
Device name	Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor
Applicant	Ivy Biomedical Systems, Inc.
Product code	DRT
Device class	Class II
Decision date	May 27, 2016
Decision	Substantially Equivalent
Regulation	870.2300

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 →

Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor

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