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FDA 510(k)

CONTEC Oxygen Concentrator

K-Number: K180837 · 2019-01-10

Decision Date2019-01-10
Product CodeCAW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CONTEC Oxygen Concentrator is the device name listed in this FDA 510(k) record. The listed applicant is Contec Medical System Co., Ltd.. It received FDA 510(k) clearance on 2019-01-10 under 510(k) 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. The listed applicant is Contec Medical System Co., Ltd.. The 510(k) number is K180837.

When did CONTEC Oxygen Concentrator receive FDA 510(k) clearance?

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

Who is the listed applicant for CONTEC Oxygen Concentrator?

The FDA 510(k) record lists Contec Medical System Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CONTEC Oxygen Concentrator?

The FDA product code for CONTEC Oxygen Concentrator is CAW.

Related Devices (Code: CAW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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