DeviceClearance

ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml)— 510(k) K173075

Substantially Equivalent

Dxnow, Inc.

FDA 510(k) clearance K173075 for ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml), Substantially Equivalent on 2018-03-08. Applicant: Dxnow, Inc..

Clearance details

Applicant
Dxnow, Inc.
Product code
Code MQK
Advisory panel
Obstetrics/Gynecology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Abbreviated
Location
Gaithersburg, MD, US
Download summary PDFView on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.