K-number	K092997
Device name	ULTRASONIC TABLETOP DOPPLER, MODELS SD5 AND SD6
Applicant	Edan Instruments, Inc.
Product code	KNG
Device class	Class II
Decision date	Nov 10, 2009
Decision	Substantially Equivalent
Regulation	884.2660

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 →

ULTRASONIC TABLETOP DOPPLER, MODELS SD5 AND SD6

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