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FDA 510(k)

MODIFICATION OF CARDIOINTEGRAM/CARDIOINTEGRAPH

K-Number: K863153 · 1987-01-06

ApplicantOcg Technology, Inc.
Decision Date1987-01-06
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION OF CARDIOINTEGRAM/CARDIOINTEGRAPH 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 1987-01-06 under 510(k) number K863153. 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 MODIFICATION OF CARDIOINTEGRAM/CARDIOINTEGRAPH?

MODIFICATION OF CARDIOINTEGRAM/CARDIOINTEGRAPH is a medical device that received FDA 510(k) clearance on 1987-01-06. The listed applicant is Ocg Technology, Inc.. The 510(k) number is K863153.

When did MODIFICATION OF CARDIOINTEGRAM/CARDIOINTEGRAPH receive FDA 510(k) clearance?

MODIFICATION OF CARDIOINTEGRAM/CARDIOINTEGRAPH received FDA 510(k) clearance on 1987-01-06, under 510(k) number K863153.

Who is the listed applicant for MODIFICATION OF CARDIOINTEGRAM/CARDIOINTEGRAPH?

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 MODIFICATION OF CARDIOINTEGRAM/CARDIOINTEGRAPH?

The FDA product code for MODIFICATION OF CARDIOINTEGRAM/CARDIOINTEGRAPH 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 2000HK812971CARDIOINTEGRAM

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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