FDA 510(k)

Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241

N.º K: K210937 · 2022-05-12

Fecha de decisión2022-05-12

Código de productoFLL

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241 is the device name listed in this FDA 510(k) record. The listed applicant is Alicn Medical Shenzhen, Inc.. It received FDA 510(k) clearance on 2022-05-12 under 510(k) number K210937. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241?

Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241 is a medical device that received FDA 510(k) clearance on 2022-05-12. The listed applicant is Alicn Medical Shenzhen, Inc.. The 510(k) number is K210937.

When did Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241 receive FDA 510(k) clearance?

Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241 received FDA 510(k) clearance on 2022-05-12, under 510(k) number K210937.

Who is the listed applicant for Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241?

The FDA 510(k) record lists Alicn Medical Shenzhen, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241?

The FDA product code for Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241 is FLL.

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Otros registros que enlistan a Alicn Medical Shenzhen, Inc. como solicitante

K232338Electronic Thermometer, Model: AET-F331, AET-F332, AET-F333, AET-F344, AET-F345, AET-F346, AET-F354, AET-F355, AET-F356, AET-F361, AET-F362, AET-F363, AET-F371, AET-F372, AET-F373, AET-F381, AET-F382, AET-F383 K231050Monitor de Presión Arterial de Brazo K230649Monitor de Presión Arterial de Brazo K222248Infrared Thermometer K221913Monitor de Presión Arterial de Brazo K210565Infrared Thermometer, Model: AET-R1B1, AET-R161, AET-R171, AET-R1D1, AET-R1D2, AET-R1F1, AET-R701, AET-R711

Ver todos los 13 dispositivos →

Dispositivos relacionados (Código: FLL)

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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.