FDA 510(k)

Intraocular Pressure Tonometer EASYTON

Номер K: K190382 · 2019-12-06

Дата решения2019-12-06

Код продуктаHKX

Консультативный комитетOP

РешениеSubstantially Equivalent

Описание устройства

Intraocular Pressure Tonometer EASYTON is the device name listed in this FDA 510(k) record. The listed applicant is Company Elamed. It received FDA 510(k) clearance on 2019-12-06 under 510(k) number K190382. 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 Intraocular Pressure Tonometer EASYTON?

Intraocular Pressure Tonometer EASYTON is a medical device that received FDA 510(k) clearance on 2019-12-06. The listed applicant is Company Elamed. The 510(k) number is K190382.

When did Intraocular Pressure Tonometer EASYTON receive FDA 510(k) clearance?

Intraocular Pressure Tonometer EASYTON received FDA 510(k) clearance on 2019-12-06, under 510(k) number K190382.

Who is the listed applicant for Intraocular Pressure Tonometer EASYTON?

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

What is the FDA product code for Intraocular Pressure Tonometer EASYTON?

The FDA product code for Intraocular Pressure Tonometer EASYTON 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.K181260MiiS Horus Scope DPT 100Medimaging Integrated Solution, Inc (Miis)K181143Keeler TonoCare TonometerKeeler Instruments, Inc.K180820Tono Vue Non-Contact TonometerCrystalvue Medical Corporation K162067VX130 Ophthalmic Diagnostic DeviceLuneau Sas

Официальный источник

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