Name: Predicase
Price: 199 USD

K-number	K131893
Device name	AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS
Applicant	Ajw Technology Consultants, Inc.
Product code	FSY
Device class	Class II
Decision date	Oct 30, 2013
Decision	Substantially Equivalent
Regulation	878.4580

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 →

AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS

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