FDA 510(k)

Appareil d'électrothérapie Combiné

Numéro K : K192087 · 2019-11-01

DemandeurShenzhen Roundwhale Technology Co. , Ltd.

Date de décision2019-11-01

Code produitNUH

Comité consultatifNE

DécisionSubstantially Equivalent

Résumé du dispositif

Combo Electrotherapy Device is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Roundwhale Technology Co. , Ltd.. It received FDA 510(k) clearance on 2019-11-01 under 510(k) number K192087. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Combo Electrotherapy Device?

Combo Electrotherapy Device is a medical device that received FDA 510(k) clearance on 2019-11-01. The listed applicant is Shenzhen Roundwhale Technology Co. , Ltd.. The 510(k) number is K192087.

When did Combo Electrotherapy Device receive FDA 510(k) clearance?

Combo Electrotherapy Device received FDA 510(k) clearance on 2019-11-01, under 510(k) number K192087.

Who is the listed applicant for Combo Electrotherapy Device?

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

What is the FDA product code for Combo Electrotherapy Device?

The FDA product code for Combo Electrotherapy Device is NUH.

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Dispositifs connexes (Code : NUH)

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Source officielle

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