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FDA 510(k)

ENGSTROM ELIZA CO2 ANALYZER

K-Number: K823049 · 1983-01-12

ApplicantLkb Instruments, Inc.
Decision Date1983-01-12
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ENGSTROM ELIZA CO2 ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Lkb Instruments, Inc.. It received FDA 510(k) clearance on 1983-01-12 under 510(k) number K823049. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENGSTROM ELIZA CO2 ANALYZER?

ENGSTROM ELIZA CO2 ANALYZER is a medical device that received FDA 510(k) clearance on 1983-01-12. The listed applicant is Lkb Instruments, Inc.. The 510(k) number is K823049.

When did ENGSTROM ELIZA CO2 ANALYZER receive FDA 510(k) clearance?

ENGSTROM ELIZA CO2 ANALYZER received FDA 510(k) clearance on 1983-01-12, under 510(k) number K823049.

Who is the listed applicant for ENGSTROM ELIZA CO2 ANALYZER?

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

What is the FDA product code for ENGSTROM ELIZA CO2 ANALYZER?

The FDA product code for ENGSTROM ELIZA CO2 ANALYZER is CCK.

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Other records listing Lkb Instruments, 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.

K8740941205 BETAPLATE LIQUID SCINTILLATION COUNTERK872955DELFIA(TM) FERRITIN KITK871303DELFIA(TM) THYROXINE (T4) KITK871599DELFIA(TM) HIGE KITK871644DELFIA (TM) HTSH KITK864452DELFIA(TM) TRIIODOTHYRONINE (T3) KIT

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Related Devices (Code: CCK)

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.

K251641GF-310R Multigas Unit (GF-310R)Nihon Kohden CorporationK261633VisuBreathAffirm Medical Technologies II, LLCK253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLCK250148Medical Gas Analyzer (AG200)Prior Care Science Technology, Ltd.K243956TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)Nihon Kohden CorporationK2512160184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling lineBarbaras Development, 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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