Name: Predicase
Price: 199 USD

K-number	K001091
Device name	CARDIOSET (HARDWARE), MODEL HO4; CARDIOSET SCL (SOFTWARE), MODEL V3.01
Applicant	Next Millennium Software Solutions, Inc.
Product code	DXH
Device class	Class II
Decision date	Aug 10, 2000
Decision	Substantially Equivalent
Regulation	870.2920

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 →

CARDIOSET (HARDWARE), MODEL HO4; CARDIOSET SCL (SOFTWARE), MODEL V3.01

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