FDA 510(k)

SpiroHome Personal, SpiroHome Clinic

Número K: K213754 · 2023-06-12

RequerenteInofab Saglik Teknolojileri A.S

Data da decisão2023-06-12

Código do produtoBZG

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

SpiroHome Personal, SpiroHome Clinic is the device name listed in this FDA 510(k) record. The listed applicant is Inofab Saglik Teknolojileri A.S. It received FDA 510(k) clearance on 2023-06-12 under 510(k) number K213754. The device is classified under product code BZG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SpiroHome Personal, SpiroHome Clinic?

SpiroHome Personal, SpiroHome Clinic is a medical device that received FDA 510(k) clearance on 2023-06-12. The listed applicant is Inofab Saglik Teknolojileri A.S. The 510(k) number is K213754.

When did SpiroHome Personal, SpiroHome Clinic receive FDA 510(k) clearance?

SpiroHome Personal, SpiroHome Clinic received FDA 510(k) clearance on 2023-06-12, under 510(k) number K213754.

Who is the listed applicant for SpiroHome Personal, SpiroHome Clinic?

The FDA 510(k) record lists Inofab Saglik Teknolojileri A.S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SpiroHome Personal, SpiroHome Clinic?

The FDA product code for SpiroHome Personal, SpiroHome Clinic is BZG.

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