FDA 510(k)

Digital Thermometer-(Model BT-301, BT-302, BT-303, BT-305, BT-306, BT-308, BT-311, BT-318)

Número K: K193621 · 2020-11-23

RequerenteDongguan E-Test Technology Co., Ltd.

Data da decisão2020-11-23

Código do produtoFLL

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Digital Thermometer-(Model BT-301, BT-302, BT-303, BT-305, BT-306, BT-308, BT-311, BT-318) is the device name listed in this FDA 510(k) record. The listed applicant is Dongguan E-Test Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-11-23 under 510(k) number K193621. 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 Digital Thermometer-(Model BT-301, BT-302, BT-303, BT-305, BT-306, BT-308, BT-311, BT-318)?

Digital Thermometer-(Model BT-301, BT-302, BT-303, BT-305, BT-306, BT-308, BT-311, BT-318) is a medical device that received FDA 510(k) clearance on 2020-11-23. The listed applicant is Dongguan E-Test Technology Co., Ltd.. The 510(k) number is K193621.

When did Digital Thermometer-(Model BT-301, BT-302, BT-303, BT-305, BT-306, BT-308, BT-311, BT-318) receive FDA 510(k) clearance?

Digital Thermometer-(Model BT-301, BT-302, BT-303, BT-305, BT-306, BT-308, BT-311, BT-318) received FDA 510(k) clearance on 2020-11-23, under 510(k) number K193621.

Who is the listed applicant for Digital Thermometer-(Model BT-301, BT-302, BT-303, BT-305, BT-306, BT-308, BT-311, BT-318)?

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

What is the FDA product code for Digital Thermometer-(Model BT-301, BT-302, BT-303, BT-305, BT-306, BT-308, BT-311, BT-318)?

The FDA product code for Digital Thermometer-(Model BT-301, BT-302, BT-303, BT-305, BT-306, BT-308, BT-311, BT-318) is FLL.

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Outros registros que listam Dongguan E-Test Technology Co., Ltd. como candidato(a)

K250231Automatic Upper Arm Blood Pressure Monitor (BA-831X, BA-832X, BA-833X, BA-837X, BA-838X, BA-842X, BA-843X, BA-845X, BA-847X, BA-849X, BA-851X, BA-852X, BA-855X, BA-835, BA-836, BA-839, BA-840, BA-856)K193628Monitor de Pressão Arterial de Pulso Automático AGE K193627Automatic Upper Arm Blood Pressure Monitor K193624Automatic Upper Arm Blood Pressure Monitor

Dispositivos Relacionados (Código: FLL)

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