Name: Predicase
Price: 199 USD

K-number	K173075
Device name	ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml)
Applicant	Dxnow, Inc.
Product code	MQK
Device class	Class II
Decision date	Mar 8, 2018
Decision	Substantially Equivalent
Regulation	884.6160

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 →

ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml)

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