FDA 510(k)

Probe Covers for Thermometers

Número K: K180714 · 2018-09-24

Data da decisão2018-09-24

Código do produtoFLL

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Probe Covers for Thermometers is the device name listed in this FDA 510(k) record. The listed applicant is K-Jump Health Co., Ltd.. It received FDA 510(k) clearance on 2018-09-24 under 510(k) number K180714. 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 Probe Covers for Thermometers?

Probe Covers for Thermometers is a medical device that received FDA 510(k) clearance on 2018-09-24. The listed applicant is K-Jump Health Co., Ltd.. The 510(k) number is K180714.

When did Probe Covers for Thermometers receive FDA 510(k) clearance?

Probe Covers for Thermometers received FDA 510(k) clearance on 2018-09-24, under 510(k) number K180714.

Who is the listed applicant for Probe Covers for Thermometers?

The FDA 510(k) record lists K-Jump Health Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Probe Covers for Thermometers?

The FDA product code for Probe Covers for Thermometers 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 K-Jump Health Co., Ltd. como candidato(a)

K170262Digital Thermometer

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.