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FDA 510(k)

OXYCHECK OXYGEN MONITOR

K-Number: K951038 · 1996-01-11

ApplicantOxycheck, Inc.
Decision Date1996-01-11
Product CodeCCL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OXYCHECK OXYGEN MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Oxycheck, Inc.. It received FDA 510(k) clearance on 1996-01-11 under 510(k) number K951038. 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 OXYCHECK OXYGEN MONITOR?

OXYCHECK OXYGEN MONITOR is a medical device that received FDA 510(k) clearance on 1996-01-11. The listed applicant is Oxycheck, Inc.. The 510(k) number is K951038.

When did OXYCHECK OXYGEN MONITOR receive FDA 510(k) clearance?

OXYCHECK OXYGEN MONITOR received FDA 510(k) clearance on 1996-01-11, under 510(k) number K951038.

Who is the listed applicant for OXYCHECK OXYGEN MONITOR?

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

What is the FDA product code for OXYCHECK OXYGEN MONITOR?

The FDA product code for OXYCHECK OXYGEN MONITOR is CCL.

Related Clinical Trials

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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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