FDA 510(k)

ReliOn Premier Classic Blood Glucose Monitoring System

N.º K: K192220 · 2019-12-13

Fecha de decisión2019-12-13

Código de productoNBW

Comité asesorCH

DecisiónSubstantially Equivalent

Resumen del dispositivo

ReliOn Premier Classic Blood Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is I-Sens, Inc.. It received FDA 510(k) clearance on 2019-12-13 under 510(k) number K192220. The device is classified under product code NBW. It was reviewed by the CH advisory panel. Product code NBW falls under the category of OB/GYN, which includes obstetric and gynecological diagnostic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the ReliOn Premier Classic Blood Glucose Monitoring System?

ReliOn Premier Classic Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2019-12-13. The listed applicant is I-Sens, Inc.. The 510(k) number is K192220.

When did ReliOn Premier Classic Blood Glucose Monitoring System receive FDA 510(k) clearance?

ReliOn Premier Classic Blood Glucose Monitoring System received FDA 510(k) clearance on 2019-12-13, under 510(k) number K192220.

Who is the listed applicant for ReliOn Premier Classic Blood Glucose Monitoring System?

The FDA 510(k) record lists I-Sens, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ReliOn Premier Classic Blood Glucose Monitoring System?

The FDA product code for ReliOn Premier Classic Blood Glucose Monitoring System is NBW. This falls under the OB/GYN category.

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Otros registros que enlistan a I-Sens, Inc. como solicitante

K230625ReliOn Premier BLU Blood Glucose Monitoring System K222656LDE4 Lancing Device K201394CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System K201551KetoSens BT Blood B-Ketone Monitoring System K192859CareSens S Clear BT Blood Glucose Monitoring System K193590CareSens S Fit BT Blood Glucose Monitoring System

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Dispositivos relacionados (Código: NBW)

K260545CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System; CONTOUR® NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care K262116TRUE METRIX Self Monitoring Blood Glucose SystemTrividia Health, Inc.K250085On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring SystemACON Laboratories, Inc.K243060TeleRPM Gen2 Blood Glucose Monitoring SystemGuangdong Transtek Medical Electronics Co., Ltd.K240637RIGHTEST Blood Glucose Monitoring System Max TelBionime Corporation K240640Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring SystemSejoy Biomedical Co., Ltd.

Fuente oficial

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