FDA 510(k)

Spirobank Oxi

K-번호: K230501 · 2023-12-15

신청자Mir Medical International Research USA

결정일2023-12-15

제품 코드BZG

자문 위원회AN

결정Substantially Equivalent

기기 요약

Spirobank Oxi is the device name listed in this FDA 510(k) record. The listed applicant is Mir Medical International Research USA. It received FDA 510(k) clearance on 2023-12-15 under 510(k) number K230501. The device is classified under product code BZG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Spirobank Oxi?

Spirobank Oxi is a medical device that received FDA 510(k) clearance on 2023-12-15. The listed applicant is Mir Medical International Research USA. The 510(k) number is K230501.

When did Spirobank Oxi receive FDA 510(k) clearance?

Spirobank Oxi received FDA 510(k) clearance on 2023-12-15, under 510(k) number K230501.

Who is the listed applicant for Spirobank Oxi?

The FDA 510(k) record lists Mir Medical International Research USA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Spirobank Oxi?

The FDA product code for Spirobank Oxi is BZG.

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Spirobank Oxi

기기 요약

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관련 임상시험

관련 기기 (코드: BZG)

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