FDA 510(k)

3M Attest Vaporizado Hidróxido de Peróxido Tri-Métrico Indicador Químico 1348/1348E

N.º K: K193110 · 2020-03-13

Fecha de decisión2020-03-13

Código de productoQKM

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E is the device name listed in this FDA 510(k) record. The listed applicant is 3M Healthcare. It received FDA 510(k) clearance on 2020-03-13 under 510(k) number K193110. The device is classified under product code QKM. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E?

3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E is a medical device that received FDA 510(k) clearance on 2020-03-13. The listed applicant is 3M Healthcare. The 510(k) number is K193110.

When did 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E receive FDA 510(k) clearance?

3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E received FDA 510(k) clearance on 2020-03-13, under 510(k) number K193110.

Who is the listed applicant for 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E?

The FDA 510(k) record lists 3M Healthcare as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E?

The FDA product code for 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E is QKM.

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Otros registros que enlistan a 3M Healthcare como solicitante

K1913553M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask K1808743M Mascarilla Quirúrgica de Alto Rendimiento, 3M Mascarilla Quirúrgica de Alto Rendimiento con Escudo Facial K1804043M Clarity Ultra Brackets Auto-Ligantes y Sistema de Dispositivo con Recubrimiento Adhesivo K1711163M™ VFlex™ Health Care Particulate Respirator and Surgical Mask, Models 1804/1804S K153571Cavilon Advanced High Endurance Skin Protectant

Dispositivos relacionados (Código: QKM)

K232103Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)Terragene S.A.K2120223M Attest Vaporizado Hidróxido de Peróxido Tri-Métrico Indicador Químico 1348/1348E3M Company K213262CELERITY HP Chemical IndicatorSTERIS Corporation K2032843M Attest Indicador Químico Trímetro de Peróxido de Hidrógeno Vaporizado3M Company

Fuente oficial

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