K122361 is an FDA 510(k) clearance for the T:CONNECT DATA MANAGEMENT SYSTEM. This device is classified as 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 FDA review panel. Regulated under 21 CFR 880.6310. 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..
| 510(k) Number | K122361 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| 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. |