Pristina Serena
K-Number: K173576 · 2018-05-14
ApplicantGE Healthcare
Decision Date2018-05-14
Product CodeMUE
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Pristina Serena is a medical device manufactured by GE Healthcare. It received FDA 510(k) clearance on 2018-05-14 under approval number K173576. The device is classified under product code MUE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Pristina Serena?
Pristina Serena is a medical device that received FDA 510(k) clearance on 2018-05-14. It is manufactured by GE Healthcare. The 510(k) number is K173576.
When was Pristina Serena approved by the FDA?
Pristina Serena received FDA 510(k) clearance on 2018-05-14, under approval number K173576.
What company makes Pristina Serena?
Pristina Serena is manufactured by GE Healthcare.
What is the FDA product code for Pristina Serena?
The FDA product code for Pristina Serena is MUE.
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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.