FDA 510(k)

No-contact Forehead Thermometer

Número K: K173048 · 2018-12-06

RequerenteDongguan Simzo Electronic Technology Co., Ltd.

Data da decisão2018-12-06

Código do produtoFLL

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

No-contact Forehead Thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Dongguan Simzo Electronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-12-06 under 510(k) number K173048. 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 No-contact Forehead Thermometer?

No-contact Forehead Thermometer is a medical device that received FDA 510(k) clearance on 2018-12-06. The listed applicant is Dongguan Simzo Electronic Technology Co., Ltd.. The 510(k) number is K173048.

When did No-contact Forehead Thermometer receive FDA 510(k) clearance?

No-contact Forehead Thermometer received FDA 510(k) clearance on 2018-12-06, under 510(k) number K173048.

Who is the listed applicant for No-contact Forehead Thermometer?

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

What is the FDA product code for No-contact Forehead Thermometer?

The FDA product code for No-contact Forehead 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

Outros registros que listam Dongguan Simzo Electronic Technology Co., Ltd. como candidato(a)

K230379Portable (Ultrasonic) Nebulizer K211583Infrared Thermometer, Model: HW-1

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.