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FDA 510(k)

KOWA GENESIS HAND-HELD FUNDUS CAMERA

K-Number: K954781 · 1995-12-01

ApplicantKowa Optimed, Inc.
Decision Date1995-12-01
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

KOWA GENESIS HAND-HELD FUNDUS CAMERA 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 1995-12-01 under 510(k) number K954781. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KOWA GENESIS HAND-HELD FUNDUS CAMERA?

KOWA GENESIS HAND-HELD FUNDUS CAMERA is a medical device that received FDA 510(k) clearance on 1995-12-01. The listed applicant is Kowa Optimed, Inc.. The 510(k) number is K954781.

When did KOWA GENESIS HAND-HELD FUNDUS CAMERA receive FDA 510(k) clearance?

KOWA GENESIS HAND-HELD FUNDUS CAMERA received FDA 510(k) clearance on 1995-12-01, under 510(k) number K954781.

Who is the listed applicant for KOWA GENESIS HAND-HELD FUNDUS CAMERA?

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 KOWA GENESIS HAND-HELD FUNDUS CAMERA?

The FDA product code for KOWA GENESIS HAND-HELD FUNDUS CAMERA is HKI.

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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-500K961090AUTOMATIC VISUAL FIELD PLOTTER AP-125K960924KOWA HAND-HELD APPLANATION TONOMETER HA-1K955442KOWA SC-1200 PHOTO SLIT LAMP SYSTEMK954780KOWA PROFESSIONAL FUNDUS CAMERA MODELS FX-500, FX-500S, FX-500CK954782KOWA PORTABLE SLIT LAMP SL-14 & SL-14B

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Related Devices (Code: HKI)

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.

K253176TearViewBeyond 700 Pty, Ltd.K251353Eyer 2Phelcom TechnologiesK252120Fundus On Phone Non Mydriatic (FOP NM-10)Remidio Innovative Solutions Private LimitedK250770Optina-4C (MHRC-C1N)Optina Diagnostics, Inc.K2436003nethra neo HD FA; 3nethra neo HDForus Health Pvt.LtdK250683Resolve Fundus CameraOptain Health, 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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