Name: Predicase
Price: 199 USD

K-number	K990113
Device name	DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4500,4530, 4533, 4539, 4540, AND 4560
Applicant	Maersk Medical A/S
Product code	DRX
Device class	Class II
Decision date	Dec 6, 1999
Decision	Substantially Equivalent
Regulation	870.2360

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 →

DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4500,4530, 4533, 4539, 4540, AND 4560

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