Name: Predicase
Price: 199 USD

K-number	K242167
Device name	Sterile and Non-Sterile Ultrasonic Coupling Agent
Applicant	Anhui Deepblue Medical Technology Co., Ltd.
Product code	MUI
Device class	Class II
Decision date	Sep 19, 2024
Decision	Substantially Equivalent
Regulation	892.1570

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 →

Sterile and Non-Sterile Ultrasonic Coupling Agent

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