Name: Predicase
Price: 199 USD

K-number	K231370
Device name	Dewin Blastocyst Medium (with HSA and without HSA)
Applicant	Donnevie Medical Technology (Shanghai) Co. , Ltd.
Product code	MQL
Device class	Class II
Decision date	Aug 4, 2023
Decision	Substantially Equivalent
Regulation	884.6180

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 →

Dewin Blastocyst Medium (with HSA and without HSA)

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