FDA 510(k)

Monitor de Presión Arterial Automático del Brazo Superior AGE con modelos BA-815, BA-816, BA-818 y BA-819

N.º K: K172895 · 2018-06-18

SolicitanteAgeless Health Industrial Co., Ltd.

Fecha de decisión2018-06-18

Código de productoDXN

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816, BA-818 and BA-819 is the device name listed in this FDA 510(k) record. The listed applicant is Ageless Health Industrial Co., Ltd.. It received FDA 510(k) clearance on 2018-06-18 under 510(k) number K172895. 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 AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816, BA-818 and BA-819?

AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816, BA-818 and BA-819 is a medical device that received FDA 510(k) clearance on 2018-06-18. The listed applicant is Ageless Health Industrial Co., Ltd.. The 510(k) number is K172895.

When did AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816, BA-818 and BA-819 receive FDA 510(k) clearance?

AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816, BA-818 and BA-819 received FDA 510(k) clearance on 2018-06-18, under 510(k) number K172895.

Who is the listed applicant for AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816, BA-818 and BA-819?

The FDA 510(k) record lists Ageless Health Industrial Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816, BA-818 and BA-819?

The FDA product code for AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816, BA-818 and BA-819 is DXN.

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Otros registros que enlistan a Ageless Health Industrial Co., Ltd. como solicitante

K172508Ageless Health Medical Digital Thermometer K153552Monitor de Presión Arterial Automático del Brazo Superior AGE

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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