FDA 510(k)

Flowtron DVT5 Small Calf Garment

Número K: K172103 · 2018-03-02

Data da decisão2018-03-02

Código do produtoJOW

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Flowtron DVT5 Small Calf Garment is the device name listed in this FDA 510(k) record. The listed applicant is Getinge (Suzhou) Co., Ltd.. It received FDA 510(k) clearance on 2018-03-02 under 510(k) number K172103. 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 Flowtron DVT5 Small Calf Garment?

Flowtron DVT5 Small Calf Garment is a medical device that received FDA 510(k) clearance on 2018-03-02. The listed applicant is Getinge (Suzhou) Co., Ltd.. The 510(k) number is K172103.

When did Flowtron DVT5 Small Calf Garment receive FDA 510(k) clearance?

Flowtron DVT5 Small Calf Garment received FDA 510(k) clearance on 2018-03-02, under 510(k) number K172103.

Who is the listed applicant for Flowtron DVT5 Small Calf Garment?

The FDA 510(k) record lists Getinge (Suzhou) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Flowtron DVT5 Small Calf Garment?

The FDA product code for Flowtron DVT5 Small Calf Garment is JOW.

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