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FDA 510(k)

NOVAVISION, MODEL 2.0

K-Number: K023623 · 2003-04-22

ApplicantNovavision, Inc.
Decision Date2003-04-22
Product CodeHPT
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

NOVAVISION, MODEL 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Novavision, Inc.. It received FDA 510(k) clearance on 2003-04-22 under 510(k) number K023623. The device is classified under product code HPT. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOVAVISION, MODEL 2.0?

NOVAVISION, MODEL 2.0 is a medical device that received FDA 510(k) clearance on 2003-04-22. The listed applicant is Novavision, Inc.. The 510(k) number is K023623.

When did NOVAVISION, MODEL 2.0 receive FDA 510(k) clearance?

NOVAVISION, MODEL 2.0 received FDA 510(k) clearance on 2003-04-22, under 510(k) number K023623.

Who is the listed applicant for NOVAVISION, MODEL 2.0?

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

What is the FDA product code for NOVAVISION, MODEL 2.0?

The FDA product code for NOVAVISION, MODEL 2.0 is HPT.

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Other records listing Novavision, 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.

K960584NOVANEW RECONDITIONING SYSTEM FOR PROF. USE IN-OFFICE USE ONLYK955900NOVALENS/NOVAWET SPHJERICAL & PERCEPTION & VANGUARD MULTIFOCAL &/OR BIFOCAL (ROSIFOCON A) RIGID GAS PERMEABLE CONTACT LR

Related Devices (Code: HPT)

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.

K092187MAIA, MODEL 1Centervue S.P.A.K093213GUIDED PROGRESSION ANALYSIS ON THE HUMPHREY FIELD ANALYZER II AND II -I SERIESCarl Zeiss Meditec, Inc.K091579FORESEE HOMENotal Vision , Ltd.K063310TRUEFIELD ANALYZERSeeing Machines LimitedK050350THE NOTAL VISION PREVIEW PREFERENTIAL HYPERACUITY PERIMETER (PREVIEW PHP)Notal Vision, Inc.K971156KASHA VISUAL FIELD SYSTEMKasha Software, Inc.

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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