FDA 510(k)

UniPulse

N.º K: K182905 · 2018-12-14

Fecha de decisión2018-12-14

Código de productoDRL

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

UniPulse is the device name listed in this FDA 510(k) record. The listed applicant is Seaward Group. It received FDA 510(k) clearance on 2018-12-14 under 510(k) number K182905. The device is classified under product code DRL. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the UniPulse?

UniPulse is a medical device that received FDA 510(k) clearance on 2018-12-14. The listed applicant is Seaward Group. The 510(k) number is K182905.

When did UniPulse receive FDA 510(k) clearance?

UniPulse received FDA 510(k) clearance on 2018-12-14, under 510(k) number K182905.

Who is the listed applicant for UniPulse?

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

What is the FDA product code for UniPulse?

The FDA product code for UniPulse is DRL.

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Fuente oficial

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