FDA 510(k)

DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto)

Número K: K180193 · 2018-02-21

RequerenteEl.En Electronic Engineering Spa

Data da decisão2018-02-21

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto) is the device name listed in this FDA 510(k) record. The listed applicant is El.En Electronic Engineering Spa. It received FDA 510(k) clearance on 2018-02-21 under 510(k) number K180193. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto)?

DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto) is a medical device that received FDA 510(k) clearance on 2018-02-21. The listed applicant is El.En Electronic Engineering Spa. The 510(k) number is K180193.

When did DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto) receive FDA 510(k) clearance?

DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto) received FDA 510(k) clearance on 2018-02-21, under 510(k) number K180193.

Who is the listed applicant for DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto)?

The FDA 510(k) record lists El.En Electronic Engineering Spa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto)?

The FDA product code for DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto) is GEX. This falls under the Gastroenterology category.

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

Outros registros que listam El.En Electronic Engineering Spa como candidato(a)

K222221DEKA HELIX K213658DEKA SMARTPERIO K212270DEKA LipoAI K211091Deka Tiac II K211362SCAR 3 K203396DEKA SMARTPERIO

Ver todos os 17 dispositivos →

Dispositivos Relacionados (Código: GEX)

K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.K252723Dynamis Pro FamilyFotona D.O.O.K241973SmartIPL_NI SystemLumenis Be, Ltd.K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.

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.