FDA 510(k)

Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-II, CP-III)

Numéro K : K190118 · 2020-05-13

DemandeurGuangzhou Xinbo Electronic Co., Ltd.

Date de décision2020-05-13

Code produitGXY

Comité consultatifNE

DécisionSubstantially Equivalent

Résumé du dispositif

Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-II, CP-III) is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Xinbo Electronic Co., Ltd.. It received FDA 510(k) clearance on 2020-05-13 under 510(k) number K190118. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-II, CP-III)?

Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-II, CP-III) is a medical device that received FDA 510(k) clearance on 2020-05-13. The listed applicant is Guangzhou Xinbo Electronic Co., Ltd.. The 510(k) number is K190118.

When did Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-II, CP-III) receive FDA 510(k) clearance?

Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-II, CP-III) received FDA 510(k) clearance on 2020-05-13, under 510(k) number K190118.

Who is the listed applicant for Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-II, CP-III)?

The FDA 510(k) record lists Guangzhou Xinbo Electronic Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-II, CP-III)?

The FDA product code for Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-II, CP-III) is GXY.

Essais cliniques associés

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Source officielle

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