FDA 510(k)

Synergy Gold (SG) Portable (Models MM011450 and MM011460)

Número K: K210124 · 2021-10-19

Data da decisão2021-10-19

Código do produtoHGX

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

Synergy Gold (SG) Portable (Models MM011450 and MM011460) is the device name listed in this FDA 510(k) record. The listed applicant is Uzinmedicare Co.. It received FDA 510(k) clearance on 2021-10-19 under 510(k) number K210124. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Synergy Gold (SG) Portable (Models MM011450 and MM011460)?

Synergy Gold (SG) Portable (Models MM011450 and MM011460) is a medical device that received FDA 510(k) clearance on 2021-10-19. The listed applicant is Uzinmedicare Co.. The 510(k) number is K210124.

When did Synergy Gold (SG) Portable (Models MM011450 and MM011460) receive FDA 510(k) clearance?

Synergy Gold (SG) Portable (Models MM011450 and MM011460) received FDA 510(k) clearance on 2021-10-19, under 510(k) number K210124.

Who is the listed applicant for Synergy Gold (SG) Portable (Models MM011450 and MM011460)?

The FDA 510(k) record lists Uzinmedicare Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Synergy Gold (SG) Portable (Models MM011450 and MM011460)?

The FDA product code for Synergy Gold (SG) Portable (Models MM011450 and MM011460) is HGX.

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Fonte oficial

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