FDA 510(k)

HIGHERDOSE Red Light Hat (HG-120K)

N.º K: K242363 · 2024-11-20

SolicitanteShenzhen Kaiyan Medical Equipment Co., Ltd.

Fecha de decisión2024-11-20

Código de productoOAP

Comité asesorPM

DecisiónSubstantially Equivalent

Resumen del dispositivo

HIGHERDOSE Red Light Hat (HG-120K) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Kaiyan Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2024-11-20 under 510(k) number K242363. The device is classified under product code OAP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the HIGHERDOSE Red Light Hat (HG-120K)?

HIGHERDOSE Red Light Hat (HG-120K) is a medical device that received FDA 510(k) clearance on 2024-11-20. The listed applicant is Shenzhen Kaiyan Medical Equipment Co., Ltd.. The 510(k) number is K242363.

When did HIGHERDOSE Red Light Hat (HG-120K) receive FDA 510(k) clearance?

HIGHERDOSE Red Light Hat (HG-120K) received FDA 510(k) clearance on 2024-11-20, under 510(k) number K242363.

Who is the listed applicant for HIGHERDOSE Red Light Hat (HG-120K)?

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

What is the FDA product code for HIGHERDOSE Red Light Hat (HG-120K)?

The FDA product code for HIGHERDOSE Red Light Hat (HG-120K) is OAP.

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Fuente oficial

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