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FDA 510(k)

CARDIOINTEGRAM

K-Number: K812971 · 1981-12-29

ApplicantOcg Technology, Inc.
Decision Date1981-12-29
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOINTEGRAM is the device name listed in this FDA 510(k) record. The listed applicant is Ocg Technology, Inc.. It received FDA 510(k) clearance on 1981-12-29 under 510(k) number K812971. 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 CARDIOINTEGRAM?

CARDIOINTEGRAM is a medical device that received FDA 510(k) clearance on 1981-12-29. The listed applicant is Ocg Technology, Inc.. The 510(k) number is K812971.

When did CARDIOINTEGRAM receive FDA 510(k) clearance?

CARDIOINTEGRAM received FDA 510(k) clearance on 1981-12-29, under 510(k) number K812971.

Who is the listed applicant for CARDIOINTEGRAM?

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

What is the FDA product code for CARDIOINTEGRAM?

The FDA product code for CARDIOINTEGRAM is DXG.

Related Clinical Trials

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.

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Other records listing Ocg Technology, 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.

K862947THE EXPERT MODELS RTS 2000 AND RTS 2000HK863153MODIFICATION OF CARDIOINTEGRAM/CARDIOINTEGRAPH

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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