FDA 510(k)

VVR Generator system

Número K: K222997 · 2023-10-25

Data da decisão2023-10-25

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

VVR Generator system is the device name listed in this FDA 510(k) record. The listed applicant is Starmed Co., Ltd.. It received FDA 510(k) clearance on 2023-10-25 under 510(k) number K222997. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the VVR Generator system?

VVR Generator system is a medical device that received FDA 510(k) clearance on 2023-10-25. The listed applicant is Starmed Co., Ltd.. The 510(k) number is K222997.

When did VVR Generator system receive FDA 510(k) clearance?

VVR Generator system received FDA 510(k) clearance on 2023-10-25, under 510(k) number K222997.

Who is the listed applicant for VVR Generator system?

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

What is the FDA product code for VVR Generator system?

The FDA product code for VVR Generator system is GEI.

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Fonte oficial

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