EMBRYOVIEWER SOFTWARE

Accessory, Assisted Reproduction

UNISENSE FERTILITECH A/S

The following data is part of a premarket notification filed by Unisense Fertilitech A/s with the FDA for Embryoviewer Software.

Pre-market Notification Details

Device IDK133712
510k NumberK133712
Device Name:EMBRYOVIEWER SOFTWARE
ClassificationAccessory, Assisted Reproduction
Applicant UNISENSE FERTILITECH A/S TUEAGER 1 Aarhus N,  DK Dk-8200
ContactHenrik Wahlgren
CorrespondentHenrik Wahlgren
UNISENSE FERTILITECH A/S TUEAGER 1 Aarhus N,  DK Dk-8200
Product CodeMQG  
CFR Regulation Number884.6120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-12-05
Decision Date2014-08-08
Summary:summary

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