FDA 510(k)

Família de Monitores Digitais de Pressão Arterial A&D TM-2657

Número K: K151953 · 2016-04-13

Data da decisão2016-04-13

Código do produtoDXN

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

A&D Medical TM-2657 Family of Digital Blood Pressure Monitors is the device name listed in this FDA 510(k) record. The listed applicant is A&D Company, Ltd.. It received FDA 510(k) clearance on 2016-04-13 under 510(k) number K151953. 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 A&D Medical TM-2657 Family of Digital Blood Pressure Monitors?

A&D Medical TM-2657 Family of Digital Blood Pressure Monitors is a medical device that received FDA 510(k) clearance on 2016-04-13. The listed applicant is A&D Company, Ltd.. The 510(k) number is K151953.

When did A&D Medical TM-2657 Family of Digital Blood Pressure Monitors receive FDA 510(k) clearance?

A&D Medical TM-2657 Family of Digital Blood Pressure Monitors received FDA 510(k) clearance on 2016-04-13, under 510(k) number K151953.

Who is the listed applicant for A&D Medical TM-2657 Family of Digital Blood Pressure Monitors?

The FDA 510(k) record lists A&D Company, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for A&D Medical TM-2657 Family of Digital Blood Pressure Monitors?

The FDA product code for A&D Medical TM-2657 Family of Digital Blood Pressure Monitors is DXN.

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Outros registros que listam A&D Company, Ltd. como candidato(a)

K212168Monitor de Pressão Arterial A&D UM-212BLE K173065Monitores de Pressão Arterial Médica A&D K173191Monitores de Pressão Arterial Médica A&D K170196Monitor Digital de Pressão Arterial UltraConnect A&D UB-1100BLE K163683Monitor Digital de Pressão Arterial UltraConnect A&D UA-1200BLE

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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