FDA 510(k)

maxmorespine Bipolar Electrodes

Número K: K211173 · 2022-06-23

Data da decisão2022-06-23

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

maxmorespine Bipolar Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Hoogland Spine Products, GmbH. It received FDA 510(k) clearance on 2022-06-23 under 510(k) number K211173. 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 maxmorespine Bipolar Electrodes?

maxmorespine Bipolar Electrodes is a medical device that received FDA 510(k) clearance on 2022-06-23. The listed applicant is Hoogland Spine Products, GmbH. The 510(k) number is K211173.

When did maxmorespine Bipolar Electrodes receive FDA 510(k) clearance?

maxmorespine Bipolar Electrodes received FDA 510(k) clearance on 2022-06-23, under 510(k) number K211173.

Who is the listed applicant for maxmorespine Bipolar Electrodes?

The FDA 510(k) record lists Hoogland Spine Products, GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for maxmorespine Bipolar Electrodes?

The FDA product code for maxmorespine Bipolar Electrodes is GEI.

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