Cleared Traditional

T:CONNECT DATA MANAGEMENT SYSTEM

K122361 · Tandem Diabetes Care, Inc. · General Hospital
Feb 2013
Decision
203d
Days
Class 1
Risk

About This 510(k) Submission

K122361 is an FDA 510(k) clearance for the T:CONNECT DATA MANAGEMENT SYSTEM, a Medical Device Data System (Class I — General Controls, product code OUG), submitted by Tandem Diabetes Care, Inc. (San Diego, US). The FDA issued a Cleared decision on February 22, 2013, 203 days after receiving the submission on August 3, 2012. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6310.

Submission Details

510(k) Number K122361 FDA.gov
FDA Decision Cleared SESE
Date Received August 03, 2012
Decision Date February 22, 2013
Days to Decision 203 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code OUG — Medical Device Data System
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.6310
Definition A Medical Device Data System (mdds) Is A Device That Is Intended To Provide One Or More Of The Following Uses, Without Controlling Or Altering The Functions Or Parameters Of Any Connected Medical Devices: (i) The Electronic Transfer Of Medical Device Data; (ii) The Electronic Storage Of Medical Device Data; (iii) The Electronic Conversion Of Medical Device Data From One Format To Another Format In Accordance With A Preset Specification; Or (iv) The Electronic Display Of Medical Device Data. (2) An Mdds May Include Software, Electronic Or Electrical Hardware Such As A Physical Communications Medium (including Wireless Hardware), Modems, Interfaces, And A Communications Protocol. This Identification Does Not Include Devices Intended To Be Used In Connection With Active Patient Monitoring.