FDA 510(k)

Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BP

Número K: K181393 · 2019-02-15

Data da decisão2019-02-15

Código do produtoKPE

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BP is the device name listed in this FDA 510(k) record. The listed applicant is Valmed S.R.L.. It received FDA 510(k) clearance on 2019-02-15 under 510(k) number K181393. The device is classified under product code KPE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BP?

Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BP is a medical device that received FDA 510(k) clearance on 2019-02-15. The listed applicant is Valmed S.R.L.. The 510(k) number is K181393.

When did Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BP receive FDA 510(k) clearance?

Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BP received FDA 510(k) clearance on 2019-02-15, under 510(k) number K181393.

Who is the listed applicant for Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BP?

The FDA 510(k) record lists Valmed S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BP?

The FDA product code for Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BP is KPE.

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