FDA 510(k)

Cloud Smart Thermometer

Número K: K160306 · 2016-12-13

RequerenteGuangzhou Bosma Technology Co, Ltd.

Data da decisão2016-12-13

Código do produtoFLL

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Cloud Smart Thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Bosma Technology Co, Ltd.. It received FDA 510(k) clearance on 2016-12-13 under 510(k) number K160306. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Cloud Smart Thermometer?

Cloud Smart Thermometer is a medical device that received FDA 510(k) clearance on 2016-12-13. The listed applicant is Guangzhou Bosma Technology Co, Ltd.. The 510(k) number is K160306.

When did Cloud Smart Thermometer receive FDA 510(k) clearance?

Cloud Smart Thermometer received FDA 510(k) clearance on 2016-12-13, under 510(k) number K160306.

Who is the listed applicant for Cloud Smart Thermometer?

The FDA 510(k) record lists Guangzhou Bosma Technology Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cloud Smart Thermometer?

The FDA product code for Cloud Smart Thermometer is FLL.

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: 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.

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.