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FDA 510(k)

T:SLIM (TM) INSULIN DELIVERY SYSTEM

K-Number: K111210 · 2011-11-09

ApplicantTandem Diabetes Care, Inc.
Decision Date2011-11-09
Product CodeLZG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

T:SLIM (TM) INSULIN DELIVERY SYSTEM 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 2011-11-09 under 510(k) number K111210. The device is classified under product code LZG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the T:SLIM (TM) INSULIN DELIVERY SYSTEM?

T:SLIM (TM) INSULIN DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 2011-11-09. The listed applicant is Tandem Diabetes Care, Inc.. The 510(k) number is K111210.

When did T:SLIM (TM) INSULIN DELIVERY SYSTEM receive FDA 510(k) clearance?

T:SLIM (TM) INSULIN DELIVERY SYSTEM received FDA 510(k) clearance on 2011-11-09, under 510(k) number K111210.

Who is the listed applicant for T:SLIM (TM) INSULIN DELIVERY SYSTEM?

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 (TM) INSULIN DELIVERY SYSTEM?

The FDA product code for T:SLIM (TM) INSULIN DELIVERY SYSTEM is LZG.

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Other records listing Tandem Diabetes Care, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260429Control-IQ+ technologyK253074Tandem Mobi insulin pump with interoperable technologyK250792t:slim X2 insulin pump with interoperable technologyK250798Control-IQ+ technologyK243823Control-IQ+ technologyK241078Tandem Mobi Insulin Pump with interoperable technology

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Related Devices (Code: LZG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262153Pivot Insulin Delivery SystemModular Medical, Inc.K253534Pivot Insulin Delivery SystemModular MedicalK240158Modular Medical MODD1 Insulin Delivery SystemModular Medical, Inc.K241622Extended Reservoir; MiniMed ReservoirMedtronic MinimedK223372Omnipod GO Insulin Delivery DeviceInsulet CorporationK210714Extended ReservoirMedtronic Minimed, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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