FDA 510(k)

Monitor de Pressão Arterial de Pulso Automático AGE

Número K: K193628 · 2020-07-12

RequerenteDongguan E-Test Technology Co., Ltd.

Data da decisão2020-07-12

Código do produtoDXN

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

AGE Automatic Wrist Blood Pressure Monitor 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 2020-07-12 under 510(k) number K193628. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the AGE Automatic Wrist Blood Pressure Monitor?

AGE Automatic Wrist Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2020-07-12. The listed applicant is Dongguan E-Test Technology Co., Ltd.. The 510(k) number is K193628.

When did AGE Automatic Wrist Blood Pressure Monitor receive FDA 510(k) clearance?

AGE Automatic Wrist Blood Pressure Monitor received FDA 510(k) clearance on 2020-07-12, under 510(k) number K193628.

Who is the listed applicant for AGE Automatic Wrist Blood Pressure Monitor?

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 AGE Automatic Wrist Blood Pressure Monitor?

The FDA product code for AGE Automatic Wrist Blood Pressure Monitor is DXN.

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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)K193621Digital Thermometer-(Model BT-301, BT-302, BT-303, BT-305, BT-306, BT-308, BT-311, BT-318)K193627Automatic Upper Arm Blood Pressure Monitor K193624Automatic Upper Arm Blood Pressure Monitor

Dispositivos Relacionados (Código: DXN)

K261929Upper Arm Blood pressure monitor (BP7155D)OMRON Healthcare, Inc.K254000Happy Health Blood Pressure MonitorHappy Health, Inc.K262658Automatic Digital Blood Pressure monitor (LD-526)Honsun (Nantong) Co., Ltd.K261394Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, DBP-62E2B Plus)JOYTECH Healthcare Co., Ltd.K253425Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P)Joytech Healthcare Co. , Ltd.K261061BP Go (BPP-855)Wellvii, Inc.

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