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FDA 510(k)

Study Watch with Irregular Pulse Monitor

N.º K: K192415 · 2020-01-17

SolicitanteVerily Life Sciences, LLC
Fecha de decisión2020-01-17
Código de productoDXH
Comité asesorCV
DecisiónSubstantially Equivalent

Resumen del dispositivo

Study Watch with Irregular Pulse Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Verily Life Sciences, LLC. It received FDA 510(k) clearance on 2020-01-17 under 510(k) number K192415. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Study Watch with Irregular Pulse Monitor?

Study Watch with Irregular Pulse Monitor is a medical device that received FDA 510(k) clearance on 2020-01-17. The listed applicant is Verily Life Sciences, LLC. The 510(k) number is K192415.

When did Study Watch with Irregular Pulse Monitor receive FDA 510(k) clearance?

Study Watch with Irregular Pulse Monitor received FDA 510(k) clearance on 2020-01-17, under 510(k) number K192415.

Who is the listed applicant for Study Watch with Irregular Pulse Monitor?

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

What is the FDA product code for Study Watch with Irregular Pulse Monitor?

The FDA product code for Study Watch with Irregular Pulse Monitor is DXH. This falls under the Hematology category.

Ensayos clínicos relacionados

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Otros registros que enlistan a Verily Life Sciences, LLC como solicitante

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.

K242508Verily Numetric Retinal CameraK213357Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse MonitorK182456Study Watch

Dispositivos relacionados (Código: DXH)

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.

K250233PreemptiveAI Clinical SDKMeasure Labs, Inc. (Dba Preemptiveai, Inc.)K250258HeartBeam AIMIGo with 12-L ECG Synthesis Software SystemHeartbeam, Inc.K243438MEMO Patch M (MPT-E08R-UNC01)Huinno Co., Ltd.K243981Hexoskin Medical System (7100-00016)Carre Technologies, Inc.K243003VitalSigns 1-Lead Holter (VSH101)VitalSigns Technology Co., Ltd.K233521QT ECG (QTERD100)QT Medical, Inc.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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