FDA 510(k)

SM Electrodes

N.º K: K183154 · 2019-03-26

SolicitanteHong Qiangxing (Shenzhen) Electronics Limited

Fecha de decisión2019-03-26

Código de productoGXY

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

SM Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Hong Qiangxing (Shenzhen) Electronics Limited. It received FDA 510(k) clearance on 2019-03-26 under 510(k) number K183154. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the SM Electrodes?

SM Electrodes is a medical device that received FDA 510(k) clearance on 2019-03-26. The listed applicant is Hong Qiangxing (Shenzhen) Electronics Limited. The 510(k) number is K183154.

When did SM Electrodes receive FDA 510(k) clearance?

SM Electrodes received FDA 510(k) clearance on 2019-03-26, under 510(k) number K183154.

Who is the listed applicant for SM Electrodes?

The FDA 510(k) record lists Hong Qiangxing (Shenzhen) Electronics Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SM Electrodes?

The FDA product code for SM Electrodes is GXY.

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Otros registros que enlistan a Hong Qiangxing (Shenzhen) Electronics Limited como solicitante

K253740TENS&EMS (HZ9151B, HZ9151C, HZ9151D)K220283TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033)K220152TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555)K220150TENS & PMS (Model: SM9126)K201354TENS & PMS K190009Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)

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Fuente oficial

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