FDA 510(k)

VX130 Ophthalmic Diagnostic Device

Номер K: K162067 · 2017-04-24

ЗаявительLuneau Sas

Дата решения2017-04-24

Код продуктаHKX

Консультативный комитетOP

РешениеSubstantially Equivalent

Описание устройства

VX130 Ophthalmic Diagnostic Device is the device name listed in this FDA 510(k) record. The listed applicant is Luneau Sas. It received FDA 510(k) clearance on 2017-04-24 under 510(k) number K162067. The device is classified under product code HKX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the VX130 Ophthalmic Diagnostic Device?

VX130 Ophthalmic Diagnostic Device is a medical device that received FDA 510(k) clearance on 2017-04-24. The listed applicant is Luneau Sas. The 510(k) number is K162067.

When did VX130 Ophthalmic Diagnostic Device receive FDA 510(k) clearance?

VX130 Ophthalmic Diagnostic Device received FDA 510(k) clearance on 2017-04-24, under 510(k) number K162067.

Who is the listed applicant for VX130 Ophthalmic Diagnostic Device?

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

What is the FDA product code for VX130 Ophthalmic Diagnostic Device?

The FDA product code for VX130 Ophthalmic Diagnostic Device is HKX.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: HKX)

K253039AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIATopcon Corporation K223739VS Tabletop TonometerMedimaging Integrated Solution, Inc.K190382Intraocular Pressure Tonometer EASYTONCompany Elamed K181260MiiS Horus Scope DPT 100Medimaging Integrated Solution, Inc (Miis)K181143Keeler TonoCare TonometerKeeler Instruments, Inc.K180820Tono Vue Non-Contact TonometerCrystalvue Medical Corporation

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