FDA 510(k)

Patent Hemostasis Band (PH Band)

Número K: K201695 · 2020-10-30

Data da decisão2020-10-30

Código do produtoDXC

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Patent Hemostasis Band (PH Band) is the device name listed in this FDA 510(k) record. The listed applicant is Medical Ingenuities. It received FDA 510(k) clearance on 2020-10-30 under 510(k) number K201695. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Patent Hemostasis Band (PH Band)?

Patent Hemostasis Band (PH Band) is a medical device that received FDA 510(k) clearance on 2020-10-30. The listed applicant is Medical Ingenuities. The 510(k) number is K201695.

When did Patent Hemostasis Band (PH Band) receive FDA 510(k) clearance?

Patent Hemostasis Band (PH Band) received FDA 510(k) clearance on 2020-10-30, under 510(k) number K201695.

Who is the listed applicant for Patent Hemostasis Band (PH Band)?

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

What is the FDA product code for Patent Hemostasis Band (PH Band)?

The FDA product code for Patent Hemostasis Band (PH Band) is DXC.

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