FDA 510(k)

Babylog VN800, Babylog VN600

N.º K: K222207 · 2023-05-16

Fecha de decisión2023-05-16

Código de productoCBK

Comité asesorAN

DecisiónSubstantially Equivalent

Resumen del dispositivo

Babylog VN800, Babylog VN600 is the device name listed in this FDA 510(k) record. The listed applicant is Draegerwerk AG & CO Kgaa. It received FDA 510(k) clearance on 2023-05-16 under 510(k) number K222207. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Babylog VN800, Babylog VN600?

Babylog VN800, Babylog VN600 is a medical device that received FDA 510(k) clearance on 2023-05-16. The listed applicant is Draegerwerk AG & CO Kgaa. The 510(k) number is K222207.

When did Babylog VN800, Babylog VN600 receive FDA 510(k) clearance?

Babylog VN800, Babylog VN600 received FDA 510(k) clearance on 2023-05-16, under 510(k) number K222207.

Who is the listed applicant for Babylog VN800, Babylog VN600?

The FDA 510(k) record lists Draegerwerk AG & CO Kgaa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Babylog VN800, Babylog VN600?

The FDA product code for Babylog VN800, Babylog VN600 is CBK.

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Otros registros que enlistan a Draegerwerk AG & CO Kgaa como solicitante

K253647Evita (V800); Evita (V600)K242769VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)K222822VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)K222024Evita V800, Evita V600 K221118CO2 Mainstream Sensor K162821Babyleo TN500

Ver todos los 7 dispositivos →

Dispositivos relacionados (Código: CBK)

K253647Evita (V800); Evita (V600)Draegerwerk AG & CO Kgaa K252663Inbentus VersatileIconic Solutions by Murcia, SL K251888VPAP Pediatric Face MaskHsiner Co., Ltd.K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.K252173F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented FullFisher & Paykel Healthcare, Ltd.K243767SV600, SV800 VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.