Gx-IVF, Gx-TL, Gx-MOPS PLUS
K-Number: K202862 · 2021-05-14
ApplicantVitrolife Sweden AB
Decision Date2021-05-14
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
Gx-IVF, Gx-TL, Gx-MOPS PLUS is a medical device manufactured by Vitrolife Sweden AB. It received FDA 510(k) clearance on 2021-05-14 under approval number K202862. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Gx-IVF, Gx-TL, Gx-MOPS PLUS?
Gx-IVF, Gx-TL, Gx-MOPS PLUS is a medical device that received FDA 510(k) clearance on 2021-05-14. It is manufactured by Vitrolife Sweden AB. The 510(k) number is K202862.
When was Gx-IVF, Gx-TL, Gx-MOPS PLUS approved by the FDA?
Gx-IVF, Gx-TL, Gx-MOPS PLUS received FDA 510(k) clearance on 2021-05-14, under approval number K202862.
What company makes Gx-IVF, Gx-TL, Gx-MOPS PLUS?
Gx-IVF, Gx-TL, Gx-MOPS PLUS is manufactured by Vitrolife Sweden AB.
What is the FDA product code for Gx-IVF, Gx-TL, Gx-MOPS PLUS?
The FDA product code for Gx-IVF, Gx-TL, Gx-MOPS PLUS is MQL.
Other Devices by Vitrolife Sweden AB
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.