510(k) K122361
K122361 is an FDA 510(k) premarket notification submitted by Tandem Diabetes Care, Inc. for the device "T:CONNECT DATA MANAGEMENT SYSTEM". The FDA issued a decision of Substantially Equivalent on February 22, 2013. The device falls under product code OUG (Medical Device Data System), a Class I device regulated under 21 CFR 880.6310. Tandem Diabetes Care, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 22, 2013
- Date Received
- August 3, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Medical Device Data System
- Device Class
- Class I
- Regulation Number
- 880.6310
- Review Panel
- HO
- Submission Type
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.