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FDA 510(k)

AUTOMATIC VISUAL FIELD PLOTTER AP-125

K-Number: K961090 · 1996-06-17

ApplicantKowa Optimed, Inc.
Decision Date1996-06-17
Product CodeHPT
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

AUTOMATIC VISUAL FIELD PLOTTER AP-125 is the device name listed in this FDA 510(k) record. The listed applicant is Kowa Optimed, Inc.. It received FDA 510(k) clearance on 1996-06-17 under 510(k) number K961090. 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 AUTOMATIC VISUAL FIELD PLOTTER AP-125?

AUTOMATIC VISUAL FIELD PLOTTER AP-125 is a medical device that received FDA 510(k) clearance on 1996-06-17. The listed applicant is Kowa Optimed, Inc.. The 510(k) number is K961090.

When did AUTOMATIC VISUAL FIELD PLOTTER AP-125 receive FDA 510(k) clearance?

AUTOMATIC VISUAL FIELD PLOTTER AP-125 received FDA 510(k) clearance on 1996-06-17, under 510(k) number K961090.

Who is the listed applicant for AUTOMATIC VISUAL FIELD PLOTTER AP-125?

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

What is the FDA product code for AUTOMATIC VISUAL FIELD PLOTTER AP-125?

The FDA product code for AUTOMATIC VISUAL FIELD PLOTTER AP-125 is HPT.

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Other records listing Kowa Optimed, 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.

K013805KOWA AUTOMATED TONOMETER KT-500K960924KOWA HAND-HELD APPLANATION TONOMETER HA-1K955442KOWA SC-1200 PHOTO SLIT LAMP SYSTEMK954780KOWA PROFESSIONAL FUNDUS CAMERA MODELS FX-500, FX-500S, FX-500CK954781KOWA GENESIS HAND-HELD FUNDUS CAMERAK954782KOWA PORTABLE SLIT LAMP SL-14 & SL-14B

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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.K023623NOVAVISION, MODEL 2.0Novavision, Inc.

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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