510(k) K142147

Device: EEVA SYSTEM
Applicant: AUXOGYN, INC.
510(k) number: K142147
Product code: PBH
Decision: Substantially Equivalent (SESE)
Decision date: 2014-11-24
Date received: 2014-08-05
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: JULIA S ANASTAS
Address: 1490 O'Brien Dr., Suite A Menlo Park CA US 94025 94025

FDA Registration Numbers#

3042372505
3009107689
3042972064

Source Documents#

Other 510(k) Records For Product Code PBH #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K250781	Embryo Predict	Alife Health	2026-05-15
K243851	CHLOE BLAST	Fairtility , Ltd.	2025-08-15
K182798	KIDScore D3	Vitrolife A/S	2019-07-19
DEN120015	EEVA 2.0	Auxogyn, Inc.	2014-06-06

Legacy Summary#

summary

FDA Review#

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