Pristina Serena Bright
K-Number: K193334 · 2020-05-15
ApplicantGE Healthcare
Decision Date2020-05-15
Product CodeMUE
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Pristina Serena Bright is a medical device manufactured by GE Healthcare. It received FDA 510(k) clearance on 2020-05-15 under approval number K193334. 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 Bright?
Pristina Serena Bright is a medical device that received FDA 510(k) clearance on 2020-05-15. It is manufactured by GE Healthcare. The 510(k) number is K193334.
When was Pristina Serena Bright approved by the FDA?
Pristina Serena Bright received FDA 510(k) clearance on 2020-05-15, under approval number K193334.
What company makes Pristina Serena Bright?
Pristina Serena Bright is manufactured by GE Healthcare.
What is the FDA product code for Pristina Serena Bright?
The FDA product code for Pristina Serena Bright 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.