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FDA 510(k)

OXYTROL

K-Number: K883590 · 1988-11-02

ApplicantCryogenic Assoc.
Decision Date1988-11-02
Product CodeNFB
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OXYTROL is the device name listed in this FDA 510(k) record. The listed applicant is Cryogenic Assoc.. It received FDA 510(k) clearance on 1988-11-02 under 510(k) number K883590. 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 OXYTROL?

OXYTROL is a medical device that received FDA 510(k) clearance on 1988-11-02. The listed applicant is Cryogenic Assoc.. The 510(k) number is K883590.

When did OXYTROL receive FDA 510(k) clearance?

OXYTROL received FDA 510(k) clearance on 1988-11-02, under 510(k) number K883590.

Who is the listed applicant for OXYTROL?

The FDA 510(k) record lists Cryogenic Assoc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OXYTROL?

The FDA product code for OXYTROL is NFB.

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 Cryogenic Assoc. 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.

K852663PORTABLE GASEOUS OXGYEN CONTAINERK841808STROLLER SPRINTK822789ROOMATE IIK800742LIBERATOR/STROLLER II SYSTEMK801104ROOMMATE-OXYGEN CONCENTRATOR

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

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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