FDA 510(k)

t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)

N.º K: K203234 · 2022-02-15

Fecha de decisión2022-02-15

Código de productoQFG

Comité asesorCH

DecisiónSubstantially Equivalent

Resumen del dispositivo

t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app) 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 2022-02-15 under 510(k) number K203234. The device is classified under product code QFG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)?

t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app) is a medical device that received FDA 510(k) clearance on 2022-02-15. The listed applicant is Tandem Diabetes Care, Inc.. The 510(k) number is K203234.

When did t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app) receive FDA 510(k) clearance?

t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app) received FDA 510(k) clearance on 2022-02-15, under 510(k) number K203234.

Who is the listed applicant for t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)?

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 X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)?

The FDA product code for t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app) is QFG.

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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: QFG)

K260001Mint ACE PumpBeta Bionics, Inc.K261672twiist Automated Insulin Delivery (AID) SystemDeka Research and Development K253976iLet ACE PumpBeta Bionics, Inc.K253743MiniMed Flex pumpMedtronic Minimed, Inc.K253470MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894)Medtronic Minimed, Inc.K253074Tandem Mobi insulin pump with interoperable technologyTandem Diabetes Care, Inc.

Fuente oficial

Ver en la base de datos de la FDA →

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