FDA 510(k)

PacTemp Automix NE

Número K: K261937 · 2026-08-07

RequerenteThe Belport Company Inc., DBA Gingi-Pak

Data da decisão2026-08-07

Código do produtoEMA

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

PacTemp Automix NE is the device name listed in this FDA 510(k) record. The listed applicant is The Belport Company Inc., DBA Gingi-Pak. It received FDA 510(k) clearance on 2026-08-07 under 510(k) number K261937. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the PacTemp Automix NE?

PacTemp Automix NE is a medical device that received FDA 510(k) clearance on 2026-08-07. The listed applicant is The Belport Company Inc., DBA Gingi-Pak. The 510(k) number is K261937.

Quando o PacTemp Automix NE recebeu a aprovação 510(k) da FDA?

PacTemp Automix NE received FDA 510(k) clearance on 2026-08-07, under 510(k) number K261937.

Who is the listed applicant for PacTemp Automix NE?

The FDA 510(k) record lists The Belport Company Inc., DBA Gingi-Pak as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PacTemp Automix NE?

The FDA product code for PacTemp Automix NE is EMA.

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Fonte oficial

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