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FDA 510(k)

CARDIOTHERM-500X

K-Number: K771718 · 1977-09-28

ApplicantColumbus Instruments Intl. Corp.
Decision Date1977-09-28
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOTHERM-500X is the device name listed in this FDA 510(k) record. The listed applicant is Columbus Instruments Intl. Corp.. It received FDA 510(k) clearance on 1977-09-28 under 510(k) number K771718. The device is classified under product code DXG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOTHERM-500X?

CARDIOTHERM-500X is a medical device that received FDA 510(k) clearance on 1977-09-28. The listed applicant is Columbus Instruments Intl. Corp.. The 510(k) number is K771718.

When did CARDIOTHERM-500X receive FDA 510(k) clearance?

CARDIOTHERM-500X received FDA 510(k) clearance on 1977-09-28, under 510(k) number K771718.

Who is the listed applicant for CARDIOTHERM-500X?

The FDA 510(k) record lists Columbus Instruments Intl. Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARDIOTHERM-500X?

The FDA product code for CARDIOTHERM-500X is DXG.

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Other records listing Columbus Instruments Intl. Corp. 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.

K895791OXYMAXK861543CARDIOMAX-IIK861100ISO-THERMEXK782036TREMOR MONITOR

Related Devices (Code: DXG)

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.

K253092Argos Infinity (Rev. 1.0)Retia Medical Systems, Inc.K251275VitalStream ART Connect; VitalStream-HemoCaretaker MedicalK232048Cogent™ Hemodynamic Monitoring System; Cogent™ HMSIcu MedicalK212529Hypotension Decision Assist Model HDA-OR2Directed Systems, Ltd.K192169PulsioFlex Monitoring System with ProAQT SensorPulsion Medical Systems SEK193179EV1000 Clinical PlatformEdwards Lifesciences, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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