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FDA 510(k)

DU PONT ISE SENSOR CARTRIDGE/REVISED TCO2 ELECTROD

K-Number: K932044 · 1993-07-27

ApplicantDupont Medical Products
Decision Date1993-07-27
Product CodeCEM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DU PONT ISE SENSOR CARTRIDGE/REVISED TCO2 ELECTROD is the device name listed in this FDA 510(k) record. The listed applicant is Dupont Medical Products. It received FDA 510(k) clearance on 1993-07-27 under 510(k) number K932044. The device is classified under product code CEM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DU PONT ISE SENSOR CARTRIDGE/REVISED TCO2 ELECTROD?

DU PONT ISE SENSOR CARTRIDGE/REVISED TCO2 ELECTROD is a medical device that received FDA 510(k) clearance on 1993-07-27. The listed applicant is Dupont Medical Products. The 510(k) number is K932044.

When did DU PONT ISE SENSOR CARTRIDGE/REVISED TCO2 ELECTROD receive FDA 510(k) clearance?

DU PONT ISE SENSOR CARTRIDGE/REVISED TCO2 ELECTROD received FDA 510(k) clearance on 1993-07-27, under 510(k) number K932044.

Who is the listed applicant for DU PONT ISE SENSOR CARTRIDGE/REVISED TCO2 ELECTROD?

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

What is the FDA product code for DU PONT ISE SENSOR CARTRIDGE/REVISED TCO2 ELECTROD?

The FDA product code for DU PONT ISE SENSOR CARTRIDGE/REVISED TCO2 ELECTROD is CEM.

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Other records listing Dupont Medical Products as applicant

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K952815DUPONT LIPASE CALIBRATORK950920DUPONT DIMENSION TOTAL PROTEIN METHODK952816LIPASE FLEX REAGENT CARTRIDGEK952412DUPONT ACA(R) URINE DRUGE OS ABUSE CONTROLK945280DUPONT DIMENSION C-REACTIVE PROTEIN METHODK944932PHENOBARBITAL FLEX REAGENT CARTRIDGE

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Related Devices (Code: CEM)

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.

K253491ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutionsRoche DiagnosticsK241037ABL90 FLEX PLUS SystemRadiometer Medicals ApsK220396EasyStat 300Medica CorporationK230890ISE ElectrodesRandox Laboratories, Ltd.K200544SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+Diamond Diagnostics, Inc.K121012FLEXLAB 3.6, ACCELERATOR A3600Inpeco S.P.A.

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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