K-number	K021574
Device name	TM2000 FETALTRACE TRANSTELEPHONIC RECEIVING CENTER
Applicant	Card Guard Scientific Survival , Ltd.
Product code	HGM
Device class	Class II
Decision date	Aug 12, 2002
Decision	Substantially Equivalent
Regulation	884.2740

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 →

Building an AI or ML-enabled device? Predicate search, PCCP tracking, and AI-specific FDA intelligence — built exclusively for AI/ML devices. Try AIFDA Intel →

TM2000 FETALTRACE TRANSTELEPHONIC RECEIVING CENTER

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