FDA 510(k)

t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater

N.º K: K160482 · 2016-07-13

Fecha de decisión2016-07-13

Código de productoLZG

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater 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 2016-07-13 under 510(k) number K160482. The device is classified under product code LZG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater?

t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater is a medical device that received FDA 510(k) clearance on 2016-07-13. The listed applicant is Tandem Diabetes Care, Inc.. The 510(k) number is K160482.

When did t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater receive FDA 510(k) clearance?

t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater received FDA 510(k) clearance on 2016-07-13, under 510(k) number K160482.

Who is the listed applicant for t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater?

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 t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater?

The FDA product code for t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater is LZG.

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Otros registros que enlistan a Tandem Diabetes Care, Inc. como solicitante

K260429Control-IQ+ technology K253074Tandem Mobi insulin pump with interoperable technology K250792t:slim X2 insulin pump with interoperable technology K250798Control-IQ+ technology K243823Control-IQ+ technology K241078Tandem Mobi Insulin Pump with interoperable technology

Ver todos los 18 dispositivos →

Dispositivos relacionados (Código: LZG)

K262153Pivot Insulin Delivery SystemModular Medical, Inc.K253534Pivot Insulin Delivery SystemModular Medical K240158Modular Medical MODD1 Insulin Delivery SystemModular Medical, Inc.K241622Extended Reservoir; MiniMed ReservoirMedtronic Minimed K223372Omnipod GO Insulin Delivery DeviceInsulet Corporation K210714Extended ReservoirMedtronic Minimed, Inc.

Fuente oficial

Ver en la base de datos de la FDA →

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