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FDA 510(k)

OXY-SERVE II OXYGEN CONSERVING REGULATOR

K-Number: K051988 · 2005-09-21

ApplicantSuperior Products, Inc.
Decision Date2005-09-21
Product CodeNFB
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OXY-SERVE II OXYGEN CONSERVING REGULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Superior Products, Inc.. It received FDA 510(k) clearance on 2005-09-21 under 510(k) number K051988. The device is classified under product code NFB. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OXY-SERVE II OXYGEN CONSERVING REGULATOR?

OXY-SERVE II OXYGEN CONSERVING REGULATOR is a medical device that received FDA 510(k) clearance on 2005-09-21. The listed applicant is Superior Products, Inc.. The 510(k) number is K051988.

When did OXY-SERVE II OXYGEN CONSERVING REGULATOR receive FDA 510(k) clearance?

OXY-SERVE II OXYGEN CONSERVING REGULATOR received FDA 510(k) clearance on 2005-09-21, under 510(k) number K051988.

Who is the listed applicant for OXY-SERVE II OXYGEN CONSERVING REGULATOR?

The FDA 510(k) record lists Superior Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OXY-SERVE II OXYGEN CONSERVING REGULATOR?

The FDA product code for OXY-SERVE II OXYGEN CONSERVING REGULATOR is NFB.

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Related Devices (Code: NFB)

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.

K250322Respond OC Conserving Regulator (130-0800)Responsive RespiratoryK220591ProximaDynasthetics, LLCK221014Effortless Oxygen Conserver System Models Effortless Pro and Effortless MobileEffortless Oxygen, LLCK200401ApogeeIncoba Ltd D/B/A DynarisK151506Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen CannulaSalter LabsK131023THERAFLOW SINGLE LUMEN AND THERAFLOW DUAL LUMENMedical Products, LLC

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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