FDA 510(k)

BLU TOTALE (Model: ENEOB852)

Número K: K232656 · 2023-11-14

Data da decisão2023-11-14

Código do produtoOLP

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

BLU TOTALE (Model: ENEOB852) is the device name listed in this FDA 510(k) record. The listed applicant is Premier North America, Inc.. It received FDA 510(k) clearance on 2023-11-14 under 510(k) number K232656. The device is classified under product code OLP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the BLU TOTALE (Model: ENEOB852)?

BLU TOTALE (Model: ENEOB852) is a medical device that received FDA 510(k) clearance on 2023-11-14. The listed applicant is Premier North America, Inc.. The 510(k) number is K232656.

When did BLU TOTALE (Model: ENEOB852) receive FDA 510(k) clearance?

BLU TOTALE (Model: ENEOB852) received FDA 510(k) clearance on 2023-11-14, under 510(k) number K232656.

Who is the listed applicant for BLU TOTALE (Model: ENEOB852)?

The FDA 510(k) record lists Premier North America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BLU TOTALE (Model: ENEOB852)?

The FDA product code for BLU TOTALE (Model: ENEOB852) is OLP.

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Fonte oficial

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