FDA 510(k)

CarpX

N.º K: K200559 · 2020-04-20

Fecha de decisión2020-04-20

Código de productoGEI

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

CarpX is the device name listed in this FDA 510(k) record. The listed applicant is Pavmed, Inc.. It received FDA 510(k) clearance on 2020-04-20 under 510(k) number K200559. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the CarpX?

CarpX is a medical device that received FDA 510(k) clearance on 2020-04-20. The listed applicant is Pavmed, Inc.. The 510(k) number is K200559.

When did CarpX receive FDA 510(k) clearance?

CarpX received FDA 510(k) clearance on 2020-04-20, under 510(k) number K200559.

Who is the listed applicant for CarpX?

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

What is the FDA product code for CarpX?

The FDA product code for CarpX is GEI.

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