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FDA 510(k)

OMNIMEDICAL QUAD I

K-Number: K812400 · 1981-10-02

ApplicantOmnimedical
Decision Date1981-10-02
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OMNIMEDICAL QUAD I is the device name listed in this FDA 510(k) record. The listed applicant is Omnimedical. It received FDA 510(k) clearance on 1981-10-02 under 510(k) number K812400. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMNIMEDICAL QUAD I?

OMNIMEDICAL QUAD I is a medical device that received FDA 510(k) clearance on 1981-10-02. The listed applicant is Omnimedical. The 510(k) number is K812400.

When did OMNIMEDICAL QUAD I receive FDA 510(k) clearance?

OMNIMEDICAL QUAD I received FDA 510(k) clearance on 1981-10-02, under 510(k) number K812400.

Who is the listed applicant for OMNIMEDICAL QUAD I?

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

What is the FDA product code for OMNIMEDICAL QUAD I?

The FDA product code for OMNIMEDICAL QUAD I is JAK.

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.

K837378OMNIMEDICAL QUAD II DIGITAL ANGIOGRAPH SYSTEMK820180CALCULI FILTER CUPK8123934001 CT SCANNERK802206OMNI SCANNER CT 6000K790673OMNIMEDICAL AUTOMATIC 1001

Related Devices (Code: JAK)

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.

K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.K261229SCENARIA View Phase 6.0Fujifilm CorporationK253836FCT iStream Phase 2Fujifilm CorporationK253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung CompanyK253770CardIQ SuiteGE Medical Systems SCSK253560Enhanced Boundary for PCCTGe Medical Systems, 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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