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FDA 510(k)

PRO2 OXYGEN ANALYZER

K-Number: K922438 · 1993-03-05

ApplicantMartech Medical Products, Inc.
Decision Date1993-03-05
Product CodeCCL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PRO2 OXYGEN ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Martech Medical Products, Inc.. It received FDA 510(k) clearance on 1993-03-05 under 510(k) number K922438. 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 PRO2 OXYGEN ANALYZER?

PRO2 OXYGEN ANALYZER is a medical device that received FDA 510(k) clearance on 1993-03-05. The listed applicant is Martech Medical Products, Inc.. The 510(k) number is K922438.

When did PRO2 OXYGEN ANALYZER receive FDA 510(k) clearance?

PRO2 OXYGEN ANALYZER received FDA 510(k) clearance on 1993-03-05, under 510(k) number K922438.

Who is the listed applicant for PRO2 OXYGEN ANALYZER?

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

What is the FDA product code for PRO2 OXYGEN ANALYZER?

The FDA product code for PRO2 OXYGEN ANALYZER is CCL.

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Other records listing Martech Medical Products, Inc. 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.

K960519MARTECH ENDOSCOPIC INJECTION NEEDLEK931924MARKSMAN ARTERIAL BLOOD GAS SYRINGEK926007ACCESSORY TO PISTON SYRINGEK914778NEOLINE(TM)K910970MARKSMAN ARTERIAL BLOOD GAS SYRINGEK890473NEEDLE GUARD(TM)

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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

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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