FDA 510(k)

Plexus SCD110 Sequential Compression Device Sleeve

Número K: K190975 · 2019-07-22

Data da decisão2019-07-22

Código do produtoJOW

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Plexus SCD110 Sequential Compression Device Sleeve is the device name listed in this FDA 510(k) record. The listed applicant is Midway Medical, LLC. It received FDA 510(k) clearance on 2019-07-22 under 510(k) number K190975. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Plexus SCD110 Sequential Compression Device Sleeve?

Plexus SCD110 Sequential Compression Device Sleeve is a medical device that received FDA 510(k) clearance on 2019-07-22. The listed applicant is Midway Medical, LLC. The 510(k) number is K190975.

When did Plexus SCD110 Sequential Compression Device Sleeve receive FDA 510(k) clearance?

Plexus SCD110 Sequential Compression Device Sleeve received FDA 510(k) clearance on 2019-07-22, under 510(k) number K190975.

Who is the listed applicant for Plexus SCD110 Sequential Compression Device Sleeve?

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

What is the FDA product code for Plexus SCD110 Sequential Compression Device Sleeve?

The FDA product code for Plexus SCD110 Sequential Compression Device Sleeve is JOW.

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