FDA 510(k)

Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C

Número K: K203332 · 2021-02-25

Data da decisão2021-02-25

Código do produtoFLL

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C is the device name listed in this FDA 510(k) record. The listed applicant is Hetaida Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-02-25 under 510(k) number K203332. 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 Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C?

Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C is a medical device that received FDA 510(k) clearance on 2021-02-25. The listed applicant is Hetaida Technology Co., Ltd.. The 510(k) number is K203332.

When did Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C receive FDA 510(k) clearance?

Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C received FDA 510(k) clearance on 2021-02-25, under 510(k) number K203332.

Who is the listed applicant for Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C?

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

What is the FDA product code for Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C?

The FDA product code for Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C 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 Hetaida Technology Co., Ltd. como candidato(a)

K243661Electronic Blood Pressure Monitor K241202Electric nasal aspirator (HTD2601US)K223170Electronic Blood Pressure Monitor, model: HTD6602US K200159Non-contact Infrared Body Thermometer, model:HTD8823US K180387Infrared Ear Thermometer K171888Non-contact infrared body thermometer

Ver todos os 8 dispositivos →

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.