FDA 510(k)

O2 Concepts Oxlife Independence Model 301-0001

K-번호: K182454 · 2018-12-20

결정일2018-12-20

제품 코드CAW

자문 위원회AN

결정Substantially Equivalent

기기 요약

O2 Concepts Oxlife Independence Model 301-0001 is the device name listed in this FDA 510(k) record. The listed applicant is O2 Concepts, LLC. It received FDA 510(k) clearance on 2018-12-20 under 510(k) number K182454. The device is classified under product code CAW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the O2 Concepts Oxlife Independence Model 301-0001?

O2 Concepts Oxlife Independence Model 301-0001 is a medical device that received FDA 510(k) clearance on 2018-12-20. The listed applicant is O2 Concepts, LLC. The 510(k) number is K182454.

When did O2 Concepts Oxlife Independence Model 301-0001 receive FDA 510(k) clearance?

O2 Concepts Oxlife Independence Model 301-0001 received FDA 510(k) clearance on 2018-12-20, under 510(k) number K182454.

Who is the listed applicant for O2 Concepts Oxlife Independence Model 301-0001?

The FDA 510(k) record lists O2 Concepts, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for O2 Concepts Oxlife Independence Model 301-0001?

The FDA product code for O2 Concepts Oxlife Independence Model 301-0001 is CAW.

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O2 Concepts Oxlife Independence Model 301-0001

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관련 임상시험

관련 기기 (코드: CAW)

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