FDA 510(k)

CliniCloud Non-contact Thermometer, Model SPL1024

N.º K: K161325 · 2016-06-22

SolicitanteStethocloud Pty.Ltd (Clinicloud)

Fecha de decisión2016-06-22

Código de productoFLL

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

CliniCloud Non-contact Thermometer, Model SPL1024 is the device name listed in this FDA 510(k) record. The listed applicant is Stethocloud Pty.Ltd (Clinicloud). It received FDA 510(k) clearance on 2016-06-22 under 510(k) number K161325. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the CliniCloud Non-contact Thermometer, Model SPL1024?

CliniCloud Non-contact Thermometer, Model SPL1024 is a medical device that received FDA 510(k) clearance on 2016-06-22. The listed applicant is Stethocloud Pty.Ltd (Clinicloud). The 510(k) number is K161325.

When did CliniCloud Non-contact Thermometer, Model SPL1024 receive FDA 510(k) clearance?

CliniCloud Non-contact Thermometer, Model SPL1024 received FDA 510(k) clearance on 2016-06-22, under 510(k) number K161325.

Who is the listed applicant for CliniCloud Non-contact Thermometer, Model SPL1024?

The FDA 510(k) record lists Stethocloud Pty.Ltd (Clinicloud) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CliniCloud Non-contact Thermometer, Model SPL1024?

The FDA product code for CliniCloud Non-contact Thermometer, Model SPL1024 is FLL.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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

Otros registros que enlistan a Stethocloud Pty.Ltd (Clinicloud) como solicitante

K173448CliniCloud Stethoscope

Dispositivos relacionados (Código: FLL)

K253162Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG)Unimed Medical Supplies, Inc.K251160Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)Shenzhen Med-Link Electronics Tech Co., Ltd.K250470Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)Shenzhen AOJ Medical Technology Co., Ltd.K243000Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)Shenzhen Medke Technology Co., Ltd.K250878YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.K243082Infrared ThermometerGuangzhou Daxin Health Technology Co., Ltd.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.