FDA 510(k)

OKLand Patient Return Electrode Pad

Número K: K183148 · 2020-02-04

RequerenteAuckland Medical Polymer(Tianjin) Co., Ltd.

Data da decisão2020-02-04

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

OKLand Patient Return Electrode Pad is the device name listed in this FDA 510(k) record. The listed applicant is Auckland Medical Polymer(Tianjin) Co., Ltd.. It received FDA 510(k) clearance on 2020-02-04 under 510(k) number K183148. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the OKLand Patient Return Electrode Pad?

OKLand Patient Return Electrode Pad is a medical device that received FDA 510(k) clearance on 2020-02-04. The listed applicant is Auckland Medical Polymer(Tianjin) Co., Ltd.. The 510(k) number is K183148.

When did OKLand Patient Return Electrode Pad receive FDA 510(k) clearance?

OKLand Patient Return Electrode Pad received FDA 510(k) clearance on 2020-02-04, under 510(k) number K183148.

Who is the listed applicant for OKLand Patient Return Electrode Pad?

The FDA 510(k) record lists Auckland Medical Polymer(Tianjin) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OKLand Patient Return Electrode Pad?

The FDA product code for OKLand Patient Return Electrode Pad is GEI.

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