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FDA 510(k)

OXITRON OXYGEN ANALYZER

K-Number: K890958 · 1989-05-22

ApplicantOxitron Medical Products
Decision Date1989-05-22
Product CodeCCL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OXITRON OXYGEN ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Oxitron Medical Products. It received FDA 510(k) clearance on 1989-05-22 under 510(k) number K890958. The device is classified under product code CCL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OXITRON OXYGEN ANALYZER?

OXITRON OXYGEN ANALYZER is a medical device that received FDA 510(k) clearance on 1989-05-22. The listed applicant is Oxitron Medical Products. The 510(k) number is K890958.

When did OXITRON OXYGEN ANALYZER receive FDA 510(k) clearance?

OXITRON OXYGEN ANALYZER received FDA 510(k) clearance on 1989-05-22, under 510(k) number K890958.

Who is the listed applicant for OXITRON OXYGEN ANALYZER?

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

What is the FDA product code for OXITRON OXYGEN ANALYZER?

The FDA product code for OXITRON OXYGEN ANALYZER is CCL.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Oxitron Medical Products 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.

K890144OXITRON OXYGEN SENSOR

Related Devices (Code: CCL)

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.

K261389PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)Salter LabsK251245OxyMinder Pro (10310)Bio-Med Device, Inc.K250002Smart Check O2 (MA0236)Life Spark Medical, LLCK221734Maxtec MaxO2 ME+pMaxtec, LLCK213933Percent Oxygen SensorsCareox, LLCK213948OxyMinderBio-Med Devices, Inc.

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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