FDA 510(k)

Blood Pressure Monitor (TMB-2287-B)

N.º K: K240102 · 2024-04-29

SolicitanteGuangdong Transtek Medical Electronics Co., Ltd.

Fecha de decisión2024-04-29

Código de productoDXN

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Blood Pressure Monitor (TMB-2287-B) is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Transtek Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2024-04-29 under 510(k) number K240102. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Blood Pressure Monitor (TMB-2287-B)?

Blood Pressure Monitor (TMB-2287-B) is a medical device that received FDA 510(k) clearance on 2024-04-29. The listed applicant is Guangdong Transtek Medical Electronics Co., Ltd.. The 510(k) number is K240102.

When did Blood Pressure Monitor (TMB-2287-B) receive FDA 510(k) clearance?

Blood Pressure Monitor (TMB-2287-B) received FDA 510(k) clearance on 2024-04-29, under 510(k) number K240102.

Who is the listed applicant for Blood Pressure Monitor (TMB-2287-B)?

The FDA 510(k) record lists Guangdong Transtek Medical Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Blood Pressure Monitor (TMB-2287-B)?

The FDA product code for Blood Pressure Monitor (TMB-2287-B) is DXN.

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Otros registros que enlistan a Guangdong Transtek Medical Electronics Co., Ltd. como solicitante

K243060TeleRPM Gen2 Blood Glucose Monitoring System K241351Blood Pressure Monitor (TMB-2092-G)K240832Blood Pressure Monitor (BBZ32-AA01)K240254Blood Pressure Monitor (TMB-2296-BT)K233130Blood Pressure Monitor K232713Blood Pressure Monitor

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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.

Fuente oficial

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