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FDA 510(k)

MODEL 02 OXYGEN ANALYZER

K-Number: K971084 · 1998-07-21

ApplicantOxigraf, Inc.
Decision Date1998-07-21
Product CodeCCL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODEL 02 OXYGEN ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Oxigraf, Inc.. It received FDA 510(k) clearance on 1998-07-21 under 510(k) number K971084. 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 MODEL 02 OXYGEN ANALYZER?

MODEL 02 OXYGEN ANALYZER is a medical device that received FDA 510(k) clearance on 1998-07-21. The listed applicant is Oxigraf, Inc.. The 510(k) number is K971084.

When did MODEL 02 OXYGEN ANALYZER receive FDA 510(k) clearance?

MODEL 02 OXYGEN ANALYZER received FDA 510(k) clearance on 1998-07-21, under 510(k) number K971084.

Who is the listed applicant for MODEL 02 OXYGEN ANALYZER?

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

What is the FDA product code for MODEL 02 OXYGEN ANALYZER?

The FDA product code for MODEL 02 OXYGEN ANALYZER is CCL.

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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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