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FDA 510(k)

KOWA AUTOMATED TONOMETER KT-500

K-Number: K013805 · 2002-10-11

ApplicantKowa Optimed, Inc.
Decision Date2002-10-11
Product CodeHKX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

KOWA AUTOMATED TONOMETER KT-500 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 2002-10-11 under 510(k) number K013805. The device is classified under product code HKX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KOWA AUTOMATED TONOMETER KT-500?

KOWA AUTOMATED TONOMETER KT-500 is a medical device that received FDA 510(k) clearance on 2002-10-11. The listed applicant is Kowa Optimed, Inc.. The 510(k) number is K013805.

When did KOWA AUTOMATED TONOMETER KT-500 receive FDA 510(k) clearance?

KOWA AUTOMATED TONOMETER KT-500 received FDA 510(k) clearance on 2002-10-11, under 510(k) number K013805.

Who is the listed applicant for KOWA AUTOMATED TONOMETER KT-500?

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 AUTOMATED TONOMETER KT-500?

The FDA product code for KOWA AUTOMATED TONOMETER KT-500 is HKX.

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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.

K961090AUTOMATIC 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-500CK954781KOWA GENESIS HAND-HELD FUNDUS CAMERAK954782KOWA PORTABLE SLIT LAMP SL-14 & SL-14B

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Related Devices (Code: HKX)

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.

K253039AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIATopcon CorporationK223739VS Tabletop TonometerMedimaging Integrated Solution, Inc.K190382Intraocular Pressure Tonometer EASYTONCompany ElamedK181260MiiS Horus Scope DPT 100Medimaging Integrated Solution, Inc (Miis)K181143Keeler TonoCare TonometerKeeler Instruments, Inc.K180820Tono Vue Non-Contact TonometerCrystalvue Medical Corporation

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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