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FDA 510(k)

OXYCHEK OXYGEN ANALYZER

K-Number: K942593 · 1995-05-03

ApplicantNidek Medical Products, Inc.
Decision Date1995-05-03
Product CodeCCL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OXYCHEK OXYGEN ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Nidek Medical Products, Inc.. It received FDA 510(k) clearance on 1995-05-03 under 510(k) number K942593. 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 OXYCHEK OXYGEN ANALYZER?

OXYCHEK OXYGEN ANALYZER is a medical device that received FDA 510(k) clearance on 1995-05-03. The listed applicant is Nidek Medical Products, Inc.. The 510(k) number is K942593.

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

OXYCHEK OXYGEN ANALYZER received FDA 510(k) clearance on 1995-05-03, under 510(k) number K942593.

Who is the listed applicant for OXYCHEK OXYGEN ANALYZER?

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

What is the FDA product code for OXYCHEK OXYGEN ANALYZER?

The FDA product code for OXYCHEK OXYGEN ANALYZER is CCL.

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Other records listing Nidek 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.

K192693Nuvo Nano Portable Oxygen ConcentratorK123738MARK 5 NUVO LITE OCSI, MARK 5 NUVO LITE STDK093308MARK 5 NUVO 8 OCSI, MARK 5 NUVO 8 STDK082566MARK 5 NUVO LITE OCSI AND STDK040892MARK 5 NUVO OCSI (M5C5), MODELS 505 AND 905K032509MARK 5 NUVO (M5C5)

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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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