510(k) K122361
- Device
- T:CONNECT DATA MANAGEMENT SYSTEM
- Applicant
- TANDEM DIABETES CARE, INC.
- 510(k) number
- K122361
- Product code
- OUG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-02-22
- Date received
- 2012-08-03
- Regulation
- 880.6310
- Classification name
- Medical Device Data System
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DON CANAL
- Address
- 11045 Roselle St. Suite 200 San Diego CA US 92121 92121
FDA Registration Numbers#
- 9615030
- 9611102
- 3009189893
- 3009171251
- 3009023553
- 2032227
- 3014111150
- 3030265385
- 3010392999
- 3011051075
- 9615010
- 3003630693
- 8043629
- 3017415521
- 3009486782
- 3013410552
- 2518897
- 3009227717
- 3003770140
- 3038294020
- 1320150
- 9610877
- 3013400546
- 3014428919
- 3015328411
- 3031158
- 3011707784
- 3008959444
- 3043041722
- 3011310592
- 3016851379
- 3003423869
- 2017865
- 2182207
- 3013003882
- 1825014
- 9615126
- 2183744
- 3010000450
- 2919016
- 3014004349
- 3014848734
- 3025306510
- 3010342382
- 2520313
- 1721964
- 3030597723
- 9680625
- 9615754
- 3030926959
- 1119779
- 3021336182
- 2027454
- 2080783
- 3015316279
- 1000227151
- 3019388613
- 1529102
- 3043479346
- 1523530
- 3037000637
- 1218950
- 3004167969
- 3007832484
- 2954323
- 9614446
- 3002807968
- 3010258456
- 3008787503
- 3016727307
- 3027204138
- 3013059683
- 9614952
- 3008699634
- 3014945378
- 3019793765
- 3012528160
- 3020978007
- 3015181391
Source Documents#
Legacy Summary#
summary
FDA Review#
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