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FDA 510(k)

Sensatronic Reusable Temperature Probes

Número K: K203643 · 2021-08-11

RequerenteSensatronic GmbH
Data da decisão2021-08-11
Código do produtoFLL
Comité consultivoHO
DecisãoSubstantially Equivalent

Resumo do dispositivo

Sensatronic Reusable Temperature Probes is the device name listed in this FDA 510(k) record. The listed applicant is Sensatronic GmbH. It received FDA 510(k) clearance on 2021-08-11 under 510(k) number K203643. 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 Sensatronic Reusable Temperature Probes?

Sensatronic Reusable Temperature Probes is a medical device that received FDA 510(k) clearance on 2021-08-11. The listed applicant is Sensatronic GmbH. The 510(k) number is K203643.

When did Sensatronic Reusable Temperature Probes receive FDA 510(k) clearance?

Sensatronic Reusable Temperature Probes received FDA 510(k) clearance on 2021-08-11, under 510(k) number K203643.

Who is the listed applicant for Sensatronic Reusable Temperature Probes?

The FDA 510(k) record lists Sensatronic GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sensatronic Reusable Temperature Probes?

The FDA product code for Sensatronic Reusable Temperature Probes is FLL.

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Dispositivos Relacionados (Código: FLL)

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.

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.

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