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FDA 510(k)

OXYGEN DEMAND VALVE

K-Number: K082345 · 2009-03-13

ApplicantBpr Medical, Ltd.
Decision Date2009-03-13
Product CodeCBP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OXYGEN DEMAND VALVE is the device name listed in this FDA 510(k) record. The listed applicant is Bpr Medical, Ltd.. It received FDA 510(k) clearance on 2009-03-13 under 510(k) number K082345. The device is classified under product code CBP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OXYGEN DEMAND VALVE?

OXYGEN DEMAND VALVE is a medical device that received FDA 510(k) clearance on 2009-03-13. The listed applicant is Bpr Medical, Ltd.. The 510(k) number is K082345.

When did OXYGEN DEMAND VALVE receive FDA 510(k) clearance?

OXYGEN DEMAND VALVE received FDA 510(k) clearance on 2009-03-13, under 510(k) number K082345.

Who is the listed applicant for OXYGEN DEMAND VALVE?

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

What is the FDA product code for OXYGEN DEMAND VALVE?

The FDA product code for OXYGEN DEMAND VALVE is CBP.

Related Clinical Trials

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.

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Other records listing Bpr Medical, Ltd. as applicant

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.

K943797BABYCARE NEO2 OXYGEN CONCENTRATION CONTROLLER

Related Devices (Code: CBP)

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.

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Official Source

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

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