K-number	K010617
Device name	SPIFE IFE CALIBRATOR AND CONTROL KIT
Applicant	Helena Laboratories
Product code	DEW
Device class	Class II
Decision date	Mar 15, 2001
Decision	Substantially Equivalent
Regulation	866.5510

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 →

SPIFE IFE CALIBRATOR AND CONTROL KIT

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