FDA 510(k)

Diacare 7000

Número K: K211207 · 2022-06-06

RequerenteGlobus Sport and Health Technologies, LLC

Data da decisão2022-06-06

Código do produtoPBX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Diacare 7000 is the device name listed in this FDA 510(k) record. The listed applicant is Globus Sport and Health Technologies, LLC. It received FDA 510(k) clearance on 2022-06-06 under 510(k) number K211207. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Diacare 7000?

Diacare 7000 is a medical device that received FDA 510(k) clearance on 2022-06-06. The listed applicant is Globus Sport and Health Technologies, LLC. The 510(k) number is K211207.

When did Diacare 7000 receive FDA 510(k) clearance?

Diacare 7000 received FDA 510(k) clearance on 2022-06-06, under 510(k) number K211207.

Who is the listed applicant for Diacare 7000?

The FDA 510(k) record lists Globus Sport and Health Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Diacare 7000?

The FDA product code for Diacare 7000 is PBX.

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