FDA 510(k)

Medline Digital Thermometer Non-Lubricated Probe Sheath

Número K: K211931 · 2021-09-20

Data da decisão2021-09-20

Código do produtoFLL

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Medline Digital Thermometer Non-Lubricated Probe Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, Inc.. It received FDA 510(k) clearance on 2021-09-20 under 510(k) number K211931. 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 Medline Digital Thermometer Non-Lubricated Probe Sheath?

Medline Digital Thermometer Non-Lubricated Probe Sheath is a medical device that received FDA 510(k) clearance on 2021-09-20. The listed applicant is Medline Industries, Inc.. The 510(k) number is K211931.

When did Medline Digital Thermometer Non-Lubricated Probe Sheath receive FDA 510(k) clearance?

Medline Digital Thermometer Non-Lubricated Probe Sheath received FDA 510(k) clearance on 2021-09-20, under 510(k) number K211931.

Who is the listed applicant for Medline Digital Thermometer Non-Lubricated Probe Sheath?

The FDA 510(k) record lists Medline Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medline Digital Thermometer Non-Lubricated Probe Sheath?

The FDA product code for Medline Digital Thermometer Non-Lubricated Probe Sheath 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 Medline Industries, Inc. como candidato(a)

K230559Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260)K223100Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14)K222665Medline UNITE® Ankle Fusion Plating System K213054Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe K212911Konig Mogen Clamp K220565Hudson RCI Triflo II Incentive Deep Breathing Exerciser

Ver todos os 74 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.