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FDA 510(k)

BABYCARE NEO2 OXYGEN CONCENTRATION CONTROLLER

K-Number: K943797 · 1995-05-11

ApplicantBpr Medical, Ltd.
Decision Date1995-05-11
Product CodeBZR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BABYCARE NEO2 OXYGEN CONCENTRATION CONTROLLER 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 1995-05-11 under 510(k) number K943797. The device is classified under product code BZR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BABYCARE NEO2 OXYGEN CONCENTRATION CONTROLLER?

BABYCARE NEO2 OXYGEN CONCENTRATION CONTROLLER is a medical device that received FDA 510(k) clearance on 1995-05-11. The listed applicant is Bpr Medical, Ltd.. The 510(k) number is K943797.

When did BABYCARE NEO2 OXYGEN CONCENTRATION CONTROLLER receive FDA 510(k) clearance?

BABYCARE NEO2 OXYGEN CONCENTRATION CONTROLLER received FDA 510(k) clearance on 1995-05-11, under 510(k) number K943797.

Who is the listed applicant for BABYCARE NEO2 OXYGEN CONCENTRATION CONTROLLER?

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 BABYCARE NEO2 OXYGEN CONCENTRATION CONTROLLER?

The FDA product code for BABYCARE NEO2 OXYGEN CONCENTRATION CONTROLLER is BZR.

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.

K082345OXYGEN DEMAND VALVE

Related Devices (Code: BZR)

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

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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