FDA 510(k)

Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503

N.º K: K193253 · 2020-06-17

SolicitanteShenzhen Changkun Technology Co., Ltd.

Fecha de decisión2020-06-17

Código de productoFLL

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503 is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Changkun Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-06-17 under 510(k) number K193253. 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 Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503?

Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503 is a medical device that received FDA 510(k) clearance on 2020-06-17. The listed applicant is Shenzhen Changkun Technology Co., Ltd.. The 510(k) number is K193253.

When did Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503 receive FDA 510(k) clearance?

Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503 received FDA 510(k) clearance on 2020-06-17, under 510(k) number K193253.

Who is the listed applicant for Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503?

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

What is the FDA product code for Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503?

The FDA product code for Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503 is FLL.

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Fuente oficial

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