FDA 510(k)

PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB)

Número K: K233132 · 2023-12-19

RequerentePrimus Sterilizer Company, LLC

Data da decisão2023-12-19

Código do produtoFLE

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB) is the device name listed in this FDA 510(k) record. The listed applicant is Primus Sterilizer Company, LLC. It received FDA 510(k) clearance on 2023-12-19 under 510(k) number K233132. The device is classified under product code FLE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB)?

PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB) is a medical device that received FDA 510(k) clearance on 2023-12-19. The listed applicant is Primus Sterilizer Company, LLC. The 510(k) number is K233132.

When did PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB) receive FDA 510(k) clearance?

PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB) received FDA 510(k) clearance on 2023-12-19, under 510(k) number K233132.

Who is the listed applicant for PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB)?

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

What is the FDA product code for PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB)?

The FDA product code for PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB) is FLE.

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Outros registros que listam Primus Sterilizer Company, LLC como candidato(a)

K221474PRIMUS Healthcare Sterilizer (Model PSS11-HC)

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Fonte oficial

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