FDA 510(k)

ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0)

N.º K: K232015 · 2023-08-03

SolicitanteAtmos Medizintechnik GmbH & Co. KG

Fecha de decisión2023-08-03

Código de productoEOB

Comité asesorEN

DecisiónSubstantially Equivalent

Resumen del dispositivo

ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0) is the device name listed in this FDA 510(k) record. The listed applicant is Atmos Medizintechnik GmbH & Co. KG. It received FDA 510(k) clearance on 2023-08-03 under 510(k) number K232015. The device is classified under product code EOB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0)?

ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0) is a medical device that received FDA 510(k) clearance on 2023-08-03. The listed applicant is Atmos Medizintechnik GmbH & Co. KG. The 510(k) number is K232015.

When did ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0) receive FDA 510(k) clearance?

ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0) received FDA 510(k) clearance on 2023-08-03, under 510(k) number K232015.

Who is the listed applicant for ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0)?

The FDA 510(k) record lists Atmos Medizintechnik GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0)?

The FDA product code for ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0) is EOB.

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Otros registros que enlistan a Atmos Medizintechnik GmbH & Co. KG como solicitante

K241799ATMOS C 051 Tórax (317.0200.0); Cilindro de secreciones 800ml (317.1300.0); Sistema de manguera (312.1177.0); Sistema de manguera con conector pequeño (312.1206.0); Sistema de manguera con conector mediano (312.1207.0); Sistema de manguera con conector grande (312.1208.0); Sistema de manguera con conector Y mediano (312.1209.0); Sistema de manguera con conector Y grande (312.1210.0); Brazalete universal para ATMOS C 051 Tórax (316.0200.0); Brazalete para ATMOS C 051 Tórax - Riel estándar (317.1160.0); Almacenamiento de carga para brazalete ATMOS C

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Fuente oficial

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