FDA 510(k)

STERIZONE VP4 Test Pack

N.º K: K203560 · 2021-03-24

SolicitanteTso3 Inc., Now A Part of Stryker

Fecha de decisión2021-03-24

Código de productoFRC

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

STERIZONE VP4 Test Pack is the device name listed in this FDA 510(k) record. The listed applicant is Tso3 Inc., Now A Part of Stryker. It received FDA 510(k) clearance on 2021-03-24 under 510(k) number K203560. The device is classified under product code FRC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the STERIZONE VP4 Test Pack?

STERIZONE VP4 Test Pack is a medical device that received FDA 510(k) clearance on 2021-03-24. The listed applicant is Tso3 Inc., Now A Part of Stryker. The 510(k) number is K203560.

When did STERIZONE VP4 Test Pack receive FDA 510(k) clearance?

STERIZONE VP4 Test Pack received FDA 510(k) clearance on 2021-03-24, under 510(k) number K203560.

Who is the listed applicant for STERIZONE VP4 Test Pack?

The FDA 510(k) record lists Tso3 Inc., Now A Part of Stryker as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERIZONE VP4 Test Pack?

The FDA product code for STERIZONE VP4 Test Pack is FRC.

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Fuente oficial

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