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PMA de la FDA

Pump, infusion, insulin, to be used with invasive glucose sensor

Número de PMA: P140015 · 2019-12-19

SolicitanteTandem Diabetes Care, Inc.
Fecha de decisión2019-12-19
Número PMAP140015
Código de productoOYC
Clase del dispositivoClase 3
Especialidad médicaU
Comité asesorCH

Resumen del dispositivo

Pump, infusion, insulin, to be used with invasive glucose sensor is the device name listed in this FDA 510(k) record. The listed applicant is Tandem Diabetes Care, Inc.. It received FDA 510(k) clearance on 2019-12-19. The device is classified under product code OYC. It was reviewed by the CH advisory panel.

Preguntas frecuentes

What is the Pump, infusion, insulin, to be used with invasive glucose sensor?

Pump, infusion, insulin, to be used with invasive glucose sensor is a medical device that received FDA 510(k) clearance on 2019-12-19. The listed applicant is Tandem Diabetes Care, Inc..

When did Pump, infusion, insulin, to be used with invasive glucose sensor receive FDA 510(k) clearance?

The clearance date for Pump, infusion, insulin, to be used with invasive glucose sensor can be found in the official FDA records.

Who is the listed applicant for Pump, infusion, insulin, to be used with invasive glucose sensor?

The FDA 510(k) record lists Tandem Diabetes Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pump, infusion, insulin, to be used with invasive glucose sensor?

The FDA product code for Pump, infusion, insulin, to be used with invasive glucose sensor is OYC.

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Fuente oficial

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