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FDA 510(k)

POTENZA

K-Number: K231216 · 2024-12-10

ApplicantJeisys Medical, Inc.
Decision Date2024-12-10
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

POTENZA is a medical device manufactured by Jeisys Medical, Inc.. It received FDA 510(k) clearance on 2024-12-10 under approval number K231216. 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 2024-12-10. It is manufactured by Jeisys Medical, Inc.. The 510(k) number is K231216.

When was POTENZA approved by the FDA?

POTENZA received FDA 510(k) clearance on 2024-12-10, under approval number K231216.

What company makes POTENZA?

POTENZA is manufactured by Jeisys Medical, Inc..

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.

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