FDA 510(k)

Mapping Suction Probe

Número K: K212164 · 2022-11-11

Data da decisão2022-11-11

Código do produtoETN

Comité consultivoEN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Mapping Suction Probe is the device name listed in this FDA 510(k) record. The listed applicant is Inomed Medizintechnik GmbH. It received FDA 510(k) clearance on 2022-11-11 under 510(k) number K212164. The device is classified under product code ETN. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Mapping Suction Probe?

Mapping Suction Probe is a medical device that received FDA 510(k) clearance on 2022-11-11. The listed applicant is Inomed Medizintechnik GmbH. The 510(k) number is K212164.

When did Mapping Suction Probe receive FDA 510(k) clearance?

Mapping Suction Probe received FDA 510(k) clearance on 2022-11-11, under 510(k) number K212164.

Who is the listed applicant for Mapping Suction Probe?

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

What is the FDA product code for Mapping Suction Probe?

The FDA product code for Mapping Suction Probe is ETN.

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