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FDA 510(k)

O2 Concepts Oxlife Independence Model 301-0001

K-Number: K182454 · 2018-12-20

ApplicantO2 Concepts, LLC
Decision Date2018-12-20
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by O2 Concepts, LLC. The 510(k) number is K182454.

When was O2 Concepts Oxlife Independence Model 301-0001 approved by the FDA?

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

What company makes O2 Concepts Oxlife Independence Model 301-0001?

O2 Concepts Oxlife Independence Model 301-0001 is manufactured by O2 Concepts, LLC.

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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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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