Gx-IVF, Gx-TL, Gx-MOPS PLUS

Media, Reproductive

Vitrolife Sweden AB

The following data is part of a premarket notification filed by Vitrolife Sweden Ab with the FDA for Gx-ivf, Gx-tl, Gx-mops Plus.

Pre-market Notification Details

Device IDK202862
510k NumberK202862
Device Name:Gx-IVF, Gx-TL, Gx-MOPS PLUS
ClassificationMedia, Reproductive
Applicant Vitrolife Sweden AB Gustaf Werners Gata 2 Vastra Frolunda,  SE 42132
ContactSarah Hood Hagberg
CorrespondentSarah Hood Hagberg
Vitrolife Sweden AB Gustaf Werners Gata 2 Vastra Frolunda,  SE 42132
Product CodeMQL  
CFR Regulation Number884.6180 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-28
Decision Date2021-05-14

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