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FDA 510(k)

CONTEC Oxygen Concentrator

K-Number: K180837 · 2019-01-10

ApplicantContec Medical System Co., Ltd.
Decision Date2019-01-10
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CONTEC Oxygen Concentrator is a medical device manufactured by Contec Medical System Co., Ltd.. It received FDA 510(k) clearance on 2019-01-10 under approval number K180837. 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 CONTEC Oxygen Concentrator?

CONTEC Oxygen Concentrator is a medical device that received FDA 510(k) clearance on 2019-01-10. It is manufactured by Contec Medical System Co., Ltd.. The 510(k) number is K180837.

When was CONTEC Oxygen Concentrator approved by the FDA?

CONTEC Oxygen Concentrator received FDA 510(k) clearance on 2019-01-10, under approval number K180837.

What company makes CONTEC Oxygen Concentrator?

CONTEC Oxygen Concentrator is manufactured by Contec Medical System Co., Ltd..

What is the FDA product code for CONTEC Oxygen Concentrator?

The FDA product code for CONTEC Oxygen Concentrator 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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