FDA 510(k)

STERLINK™ FPS-15s Plus esterilizador com cassetę STERPACK™ plus

Número K: K223015 · 2023-05-09

Data da decisão2023-05-09

Código do produtoMLR

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette is the device name listed in this FDA 510(k) record. The listed applicant is Plasmapp Co,., Ltd.. It received FDA 510(k) clearance on 2023-05-09 under 510(k) number K223015. The device is classified under product code MLR. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette?

STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette is a medical device that received FDA 510(k) clearance on 2023-05-09. The listed applicant is Plasmapp Co,., Ltd.. The 510(k) number is K223015.

When did STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette receive FDA 510(k) clearance?

STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette received FDA 510(k) clearance on 2023-05-09, under 510(k) number K223015.

Who is the listed applicant for STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette?

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

What is the FDA product code for STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette?

The FDA product code for STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette is MLR.

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Outros registros que listam Plasmapp Co,., Ltd. como candidato(a)

K231169STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)K223025Tyvek Roll with CI for STERLINK Sterilizer K223023Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)K220345STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer; Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)K212198Tyvek(R) Roll with CI for STERLINKTM Sterilizer K212193Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)

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