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510(k) K182798

Device
KIDScore D3
Applicant
Vitrolife A/S
510(k) number
K182798
Product code
PBH  
Decision
Substantially Equivalent (SESE)
Decision date
2019-07-19
Date received
2018-10-02
Regulation
884.6195
Classification name
Embryo Image Assessment System, Assisted Reproduction
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Belinda Dueholm
Address
Jens Juuls Vej 20 Viby J DK 8260 8260

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PBH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K250781Embryo PredictAlife Health2026-05-15
K243851CHLOE BLASTFairtility , Ltd.2025-08-15
K142147EEVA SYSTEMAuxogyn, Inc.2014-11-24
DEN120015EEVA 2.0Auxogyn, Inc.2014-06-06

Legacy Summary#

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FDA Review#

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