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FDA 510(k)

Potenza

K-Number: K201685 · 2021-01-19

ApplicantJeisys Medical, Inc.
Decision Date2021-01-19
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Potenza is the device name listed in this FDA 510(k) record. The listed applicant is Jeisys Medical, Inc.. It received FDA 510(k) clearance on 2021-01-19 under 510(k) number K201685. 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 2021-01-19. The listed applicant is Jeisys Medical, Inc.. The 510(k) number is K201685.

When did Potenza receive FDA 510(k) clearance?

Potenza received FDA 510(k) clearance on 2021-01-19, under 510(k) number K201685.

Who is the listed applicant for Potenza?

The FDA 510(k) record lists Jeisys Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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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