FDA 510(k)

Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01

Número K: K212377 · 2022-04-15

RequerenteNingbo Medkinetic Medical Device Co., Ltd.

Data da decisão2022-04-15

Código do produtoNUH

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01 is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Medkinetic Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2022-04-15 under 510(k) number K212377. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01?

Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01 is a medical device that received FDA 510(k) clearance on 2022-04-15. The listed applicant is Ningbo Medkinetic Medical Device Co., Ltd.. The 510(k) number is K212377.

When did Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01 receive FDA 510(k) clearance?

Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01 received FDA 510(k) clearance on 2022-04-15, under 510(k) number K212377.

Who is the listed applicant for Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01?

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

What is the FDA product code for Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01?

The FDA product code for Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01 is NUH.

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