FDA 510(k)

Heat Pain Pro

N.º K: K181992 · 2018-11-09

Fecha de decisión2018-11-09

Código de productoNUH

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Heat Pain Pro is the device name listed in this FDA 510(k) record. The listed applicant is Omron Healthcare, Inc.. It received FDA 510(k) clearance on 2018-11-09 under 510(k) number K181992. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Heat Pain Pro?

Heat Pain Pro is a medical device that received FDA 510(k) clearance on 2018-11-09. The listed applicant is Omron Healthcare, Inc.. The 510(k) number is K181992.

When did Heat Pain Pro receive FDA 510(k) clearance?

Heat Pain Pro received FDA 510(k) clearance on 2018-11-09, under 510(k) number K181992.

Who is the listed applicant for Heat Pain Pro?

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

What is the FDA product code for Heat Pain Pro?

The FDA product code for Heat Pain Pro is NUH.

Otros registros que enlistan a Omron Healthcare, Inc. como solicitante

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Fuente oficial

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