FDA 510(k)

Keeler TonoCare Tonometer

Número K: K181143 · 2019-02-08

Data da decisão2019-02-08

Código do produtoHKX

Comité consultivoOP

DecisãoSubstantially Equivalent

Resumo do dispositivo

Keeler TonoCare Tonometer is the device name listed in this FDA 510(k) record. The listed applicant is Keeler Instruments, Inc.. It received FDA 510(k) clearance on 2019-02-08 under 510(k) number K181143. The device is classified under product code HKX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Keeler TonoCare Tonometer?

Keeler TonoCare Tonometer is a medical device that received FDA 510(k) clearance on 2019-02-08. The listed applicant is Keeler Instruments, Inc.. The 510(k) number is K181143.

When did Keeler TonoCare Tonometer receive FDA 510(k) clearance?

Keeler TonoCare Tonometer received FDA 510(k) clearance on 2019-02-08, under 510(k) number K181143.

Who is the listed applicant for Keeler TonoCare Tonometer?

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

What is the FDA product code for Keeler TonoCare Tonometer?

The FDA product code for Keeler TonoCare Tonometer is HKX.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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

Dispositivos Relacionados (Código: HKX)

K253039AUTO KERATO-REFRACTO TONÔMETRO TRK-3 OMNIATopcon Corporation K223739VS Tabletop TonometerMedimaging Integrated Solution, Inc.K190382Intraocular Pressure Tonometer EASYTONCompany Elamed K181260MiiS Horus Scope DPT 100Medimaging Integrated Solution, Inc (Miis)K180820Tono Vue Non-Contact TonometerCrystalvue Medical Corporation K162067VX130 Ophthalmic Diagnostic DeviceLuneau Sas

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.