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.. Device class: 2.

Clearance details

Applicant
Dxnow, Inc.
Product code
Product code MQK
Device class
Class 2
Regulation
21 CFR 884.6160
Advisory panel
Obstetrics/Gynecology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Abbreviated
Location
Gaithersburg, MD, US
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