RapidVit Oocyte, RapidWarm Oocyte
K-Number: K183486 · 2019-07-26
ApplicantVitrolife Sweden AB
Decision Date2019-07-26
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
RapidVit Oocyte, RapidWarm Oocyte is a medical device manufactured by Vitrolife Sweden AB. It received FDA 510(k) clearance on 2019-07-26 under approval number K183486. 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 RapidVit Oocyte, RapidWarm Oocyte?
RapidVit Oocyte, RapidWarm Oocyte is a medical device that received FDA 510(k) clearance on 2019-07-26. It is manufactured by Vitrolife Sweden AB. The 510(k) number is K183486.
When was RapidVit Oocyte, RapidWarm Oocyte approved by the FDA?
RapidVit Oocyte, RapidWarm Oocyte received FDA 510(k) clearance on 2019-07-26, under approval number K183486.
What company makes RapidVit Oocyte, RapidWarm Oocyte?
RapidVit Oocyte, RapidWarm Oocyte is manufactured by Vitrolife Sweden AB.
What is the FDA product code for RapidVit Oocyte, RapidWarm Oocyte?
The FDA product code for RapidVit Oocyte, RapidWarm Oocyte is MQL.
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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.