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FDA 510(k)

T:CONNECT DATA MANAGEMENT SYSTEM

K-Number: K122361 · 2013-02-22

ApplicantTandem Diabetes Care, Inc.
Decision Date2013-02-22
Product CodeOUG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

T:CONNECT DATA MANAGEMENT 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 2013-02-22 under 510(k) number K122361. The device is classified under product code OUG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the T:CONNECT DATA MANAGEMENT SYSTEM?

T:CONNECT DATA MANAGEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2013-02-22. The listed applicant is Tandem Diabetes Care, Inc.. The 510(k) number is K122361.

When did T:CONNECT DATA MANAGEMENT SYSTEM receive FDA 510(k) clearance?

T:CONNECT DATA MANAGEMENT SYSTEM received FDA 510(k) clearance on 2013-02-22, under 510(k) number K122361.

Who is the listed applicant for T:CONNECT DATA MANAGEMENT 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:CONNECT DATA MANAGEMENT SYSTEM?

The FDA product code for T:CONNECT DATA MANAGEMENT SYSTEM is OUG.

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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.

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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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