FDA 510(k)

Breezing Med

Número K: K200076 · 2020-09-25

Data da decisão2020-09-25

Código do produtoBZL

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Breezing Med is the device name listed in this FDA 510(k) record. The listed applicant is Tf Health Co.. It received FDA 510(k) clearance on 2020-09-25 under 510(k) number K200076. The device is classified under product code BZL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Breezing Med?

Breezing Med is a medical device that received FDA 510(k) clearance on 2020-09-25. The listed applicant is Tf Health Co.. The 510(k) number is K200076.

When did Breezing Med receive FDA 510(k) clearance?

Breezing Med received FDA 510(k) clearance on 2020-09-25, under 510(k) number K200076.

Who is the listed applicant for Breezing Med?

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

What is the FDA product code for Breezing Med?

The FDA product code for Breezing Med is BZL.

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