Potenza
K-Number: K192545 · 2020-02-20
ApplicantJeisys Medical Incorporated
Decision Date2020-02-20
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Potenza is a medical device manufactured by Jeisys Medical Incorporated. It received FDA 510(k) clearance on 2020-02-20 under approval number K192545. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Potenza?
Potenza is a medical device that received FDA 510(k) clearance on 2020-02-20. It is manufactured by Jeisys Medical Incorporated. The 510(k) number is K192545.
When was Potenza approved by the FDA?
Potenza received FDA 510(k) clearance on 2020-02-20, under approval number K192545.
What company makes Potenza?
Potenza is manufactured by Jeisys Medical Incorporated.
What is the FDA product code for Potenza?
The FDA product code for Potenza is GEI.
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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.