Name: Predicase
Price: 199 USD

K-number	K041644
Device name	FLEXI-STAT DISPOSABLE NON-ADHESIVE SPO2 SENSORS, (NELLCOR-COMPATIBLE), (BCI-COMPATIBLE), (DATEX-COMPATIBLE)
Applicant	Elekon Industries U.S.A., Inc.
Product code	DQA
Device class	Class II
Decision date	Jul 29, 2004
Decision	Substantially Equivalent
Regulation	870.2700

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 →

FLEXI-STAT DISPOSABLE NON-ADHESIVE SPO2 SENSORS, (NELLCOR-COMPATIBLE), (BCI-COMPATIBLE), (DATEX-COMPATIBLE)

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