FDA 510(k)

VS Tabletop Tonometer

Номер K: K223739 · 2023-11-08

ЗаявительMedimaging Integrated Solution, Inc.

Дата решения2023-11-08

Код продуктаHKX

Консультативный комитетOP

РешениеSubstantially Equivalent

Описание устройства

VS Tabletop Tonometer is the device name listed in this FDA 510(k) record. The listed applicant is Medimaging Integrated Solution, Inc.. It received FDA 510(k) clearance on 2023-11-08 under 510(k) number K223739. 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 VS Tabletop Tonometer?

VS Tabletop Tonometer is a medical device that received FDA 510(k) clearance on 2023-11-08. The listed applicant is Medimaging Integrated Solution, Inc.. The 510(k) number is K223739.

When did VS Tabletop Tonometer receive FDA 510(k) clearance?

VS Tabletop Tonometer received FDA 510(k) clearance on 2023-11-08, under 510(k) number K223739.

Who is the listed applicant for VS Tabletop Tonometer?

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

What is the FDA product code for VS Tabletop Tonometer?

The FDA product code for VS Tabletop Tonometer 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Связанные устройства (Код: HKX)

K253039AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIATopcon Corporation 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 K162067VX130 Ophthalmic Diagnostic DeviceLuneau Sas

Официальный источник

Посмотреть в базе данных FDA →

Данные получены из открытого API FDA. Для получения наиболее актуальной и авторитетной информации всегда обращайтесь к официальным записям.