FDA 510(k)

Waypoint GPS

Número K: K222106 · 2023-05-12

Data da decisão2023-05-12

Código do produtoQWP

Comité consultivoEN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Waypoint GPS is the device name listed in this FDA 510(k) record. The listed applicant is Waypoint Orthopedics, Inc.. It received FDA 510(k) clearance on 2023-05-12 under 510(k) number K222106. The device is classified under product code QWP. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Waypoint GPS?

Waypoint GPS is a medical device that received FDA 510(k) clearance on 2023-05-12. The listed applicant is Waypoint Orthopedics, Inc.. The 510(k) number is K222106.

When did Waypoint GPS receive FDA 510(k) clearance?

Waypoint GPS received FDA 510(k) clearance on 2023-05-12, under 510(k) number K222106.

Who is the listed applicant for Waypoint GPS?

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

What is the FDA product code for Waypoint GPS?

The FDA product code for Waypoint GPS is QWP.

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