EMBRYO VIEWER SOFTWARE— 510(k) K113075

Substantially Equivalent

Unisense Fertilitech A/S

FDA 510(k) clearance K113075 for EMBRYO VIEWER SOFTWARE, Substantially Equivalent on 2011-12-21. Applicant: Unisense Fertilitech A/S. Device class: 2.

Clearance details

Applicant
Unisense Fertilitech A/S
Product code
Code MQG
Device class
Class 2
Regulation
21 CFR 884.6120
Advisory panel
Obstetrics/Gynecology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Arrhus N, DK
Download summary PDFView on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.