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FDA 510(k)

BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)

N.º K: K253152 · 2026-05-06

SolicitanteBiozen, LLC
Fecha de decisión2026-05-06
Código de productoDXN
Comité asesorCV
DecisiónSubstantially Equivalent

Resumen del dispositivo

BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000) is the device name listed in this FDA 510(k) record. The listed applicant is Biozen, LLC. It received FDA 510(k) clearance on 2026-05-06 under 510(k) number K253152. 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 BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)?

BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000) is a medical device that received FDA 510(k) clearance on 2026-05-06. The listed applicant is Biozen, LLC. The 510(k) number is K253152.

When did BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000) receive FDA 510(k) clearance?

BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000) received FDA 510(k) clearance on 2026-05-06, under 510(k) number K253152.

Who is the listed applicant for BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)?

The FDA 510(k) record lists Biozen, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)?

The FDA product code for BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000) is DXN.

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Dispositivos relacionados (Código: DXN)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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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