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FDA 510(k)

SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G

K-Number: K023745 · 2003-01-17

ApplicantSechrist Industries, Inc.
Decision Date2003-01-17
Product CodeDTX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G is the device name listed in this FDA 510(k) record. The listed applicant is Sechrist Industries, Inc.. It received FDA 510(k) clearance on 2003-01-17 under 510(k) number K023745. The device is classified under product code DTX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G?

SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G is a medical device that received FDA 510(k) clearance on 2003-01-17. The listed applicant is Sechrist Industries, Inc.. The 510(k) number is K023745.

When did SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G receive FDA 510(k) clearance?

SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G received FDA 510(k) clearance on 2003-01-17, under 510(k) number K023745.

Who is the listed applicant for SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G?

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

What is the FDA product code for SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G?

The FDA product code for SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G is DTX.

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Other records listing Sechrist Industries, 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.

K100268SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBERK052713MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBERK993167MILLENNIUM INFANT VENTILATORK992503SECHRIST AIR-OXYGEN MIXER, 3500/3500HL SERIESK934164MODEL 2500E/2500ER HYPERBARIC CHAMBERK950386MODEL 3200P/3200PR HYPERBARIC CHAMBER

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Related Devices (Code: DTX)

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.

K210669Quantum Mini Ventilation ModuleSpectrum Medical , Ltd.K202733Quantum Ventilation ModuleSpectrum Medical , Ltd.K181942Quantum Ventilation ModuleSpectrum Medical , Ltd.K101046STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEMSorin Group Deutschland GmbHK965214COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002)Coeur Laboratories, Inc.K863902MODIFIED SARNS MEMBRANE OXYGENATOR3M Health Care, Sarns

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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