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FDA 510(k)

THE OPHTHIMUS SYSTEM

K-Number: K896017 · 1990-10-02

ApplicantHightech Vision
Decision Date1990-10-02
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

THE OPHTHIMUS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hightech Vision. It received FDA 510(k) clearance on 1990-10-02 under 510(k) number K896017. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE OPHTHIMUS SYSTEM?

THE OPHTHIMUS SYSTEM is a medical device that received FDA 510(k) clearance on 1990-10-02. The listed applicant is Hightech Vision. The 510(k) number is K896017.

When did THE OPHTHIMUS SYSTEM receive FDA 510(k) clearance?

THE OPHTHIMUS SYSTEM received FDA 510(k) clearance on 1990-10-02, under 510(k) number K896017.

Who is the listed applicant for THE OPHTHIMUS SYSTEM?

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

What is the FDA product code for THE OPHTHIMUS SYSTEM?

The FDA product code for THE OPHTHIMUS SYSTEM is DQK.

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Related Devices (Code: DQK)

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.

K261729EnSite™ X EP SystemAbbott MedicalK262005Affera Integrated Mapping SystemMedtronic, Inc.K253692AVVIGO™+ Multi-Modality Guidance SystemBoston ScientificK253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott MedicalK252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, 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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