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FDA 510(k)

OMNIMEDICAL QUAD II DIGITAL ANGIOGRAPH SYSTEM

K-Number: K837378 · 1983-05-18

ApplicantOmnimedical
Decision Date1983-05-18
Product Code
DecisionSubstantially Equivalent

Device Summary

OMNIMEDICAL QUAD II DIGITAL ANGIOGRAPH SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Omnimedical. It received FDA 510(k) clearance on 1983-05-18 under 510(k) number K837378. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMNIMEDICAL QUAD II DIGITAL ANGIOGRAPH SYSTEM?

OMNIMEDICAL QUAD II DIGITAL ANGIOGRAPH SYSTEM is a medical device that received FDA 510(k) clearance on 1983-05-18. The listed applicant is Omnimedical. The 510(k) number is K837378.

When did OMNIMEDICAL QUAD II DIGITAL ANGIOGRAPH SYSTEM receive FDA 510(k) clearance?

OMNIMEDICAL QUAD II DIGITAL ANGIOGRAPH SYSTEM received FDA 510(k) clearance on 1983-05-18, under 510(k) number K837378.

Who is the listed applicant for OMNIMEDICAL QUAD II DIGITAL ANGIOGRAPH SYSTEM?

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

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 Omnimedical 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.

K820180CALCULI FILTER CUPK8123934001 CT SCANNERK812400OMNIMEDICAL QUAD IK802206OMNI SCANNER CT 6000K790673OMNIMEDICAL AUTOMATIC 1001

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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