FDA 510(k)

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

Número K: K160482 · 2016-07-13

Data da decisão2016-07-13

Código do produtoLZG

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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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Outros registros que listam Tandem Diabetes Care, Inc. como candidato(a)

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

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Fonte oficial

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