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FDA 510(k)

HEM-O-SCAN OXYGEN EQUIL. CURVE ANALYZER

K-Number: K802379 · 1980-10-31

ApplicantAmerican Instrument Co.
Decision Date1980-10-31
Product CodeLCH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HEM-O-SCAN OXYGEN EQUIL. CURVE ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is American Instrument Co.. It received FDA 510(k) clearance on 1980-10-31 under 510(k) number K802379. The device is classified under product code LCH. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEM-O-SCAN OXYGEN EQUIL. CURVE ANALYZER?

HEM-O-SCAN OXYGEN EQUIL. CURVE ANALYZER is a medical device that received FDA 510(k) clearance on 1980-10-31. The listed applicant is American Instrument Co.. The 510(k) number is K802379.

When did HEM-O-SCAN OXYGEN EQUIL. CURVE ANALYZER receive FDA 510(k) clearance?

HEM-O-SCAN OXYGEN EQUIL. CURVE ANALYZER received FDA 510(k) clearance on 1980-10-31, under 510(k) number K802379.

Who is the listed applicant for HEM-O-SCAN OXYGEN EQUIL. CURVE ANALYZER?

The FDA 510(k) record lists American Instrument Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEM-O-SCAN OXYGEN EQUIL. CURVE ANALYZER?

The FDA product code for HEM-O-SCAN OXYGEN EQUIL. CURVE ANALYZER is LCH.

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Related Devices (Code: LCH)

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.

K922386RNA MEDICAL TONOMETERBionostics, Inc.K904163CLINICAL BLOOD GAS MIXTURESNorco, Inc.K900819BLOOD GAS CALIBRATION STANDARDCryogenic Rare Gas Laboratories, Inc.K862958AMR RESEARCH TONOMETERAssociated Medical RepresentativesK841089LINEAR CLOUD TONOMETERLinear Tonometers, Inc.K801599CORNING 184 BLOOD GAS TONOMETERCorning Medical & Scientific

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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