FDA 510(k)

Practical Navigation Surgical Guidance System (PNSGS)

N.º K: K202184 · 2021-02-24

Fecha de decisión2021-02-24

Código de productoOLO

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Practical Navigation Surgical Guidance System (PNSGS) is the device name listed in this FDA 510(k) record. The listed applicant is Practical Navigation, LLC. It received FDA 510(k) clearance on 2021-02-24 under 510(k) number K202184. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Practical Navigation Surgical Guidance System (PNSGS)?

Practical Navigation Surgical Guidance System (PNSGS) is a medical device that received FDA 510(k) clearance on 2021-02-24. The listed applicant is Practical Navigation, LLC. The 510(k) number is K202184.

When did Practical Navigation Surgical Guidance System (PNSGS) receive FDA 510(k) clearance?

Practical Navigation Surgical Guidance System (PNSGS) received FDA 510(k) clearance on 2021-02-24, under 510(k) number K202184.

Who is the listed applicant for Practical Navigation Surgical Guidance System (PNSGS)?

The FDA 510(k) record lists Practical Navigation, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Practical Navigation Surgical Guidance System (PNSGS)?

The FDA product code for Practical Navigation Surgical Guidance System (PNSGS) is OLO.

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Fuente oficial

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