T:CONNECT DATA MANAGEMENT SYSTEM— 510(k) K122361

Name: FDA 510(k) clearance K122361
Creator: U.S. Food and Drug Administration
Published: 2013-02-22

Substantially Equivalent

Tandem Diabetes Care, Inc.

FDA 510(k) clearance K122361 for T:CONNECT DATA MANAGEMENT SYSTEM, Substantially Equivalent on 2013-02-22. Applicant: Tandem Diabetes Care, Inc.. Device class: 1.

Clearance details

Applicant: Tandem Diabetes Care, Inc.
Product code: Code OUG
Device class: Class 1
Regulation: 21 CFR 880.6310
Advisory panel: General Hospital
Date received: 2012-08-03
Decision date: 2013-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code OUG

product code OUG

Malfunction: 2,311
Other: 12
Total: 2,323

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.