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#
- 3027339877
- 3004363352
- 3009555440
- 8043933
- 3019545235
- 9611252
- 3010120339
- 3003477135
- 3029300449
- 3026566521
- 2017865
- 3044827674
- 3002807968
- 2936999
- 3014428919
- 8030931
- 3038356864
- 3018094310
- 3002879653
- 3042972750
- 2954323
- 2133641
- 3009715978
- 3008881835
- 3009227717
- 3007923088
- 3016851379
- 3037000637
- 3009144084
- 9615754
- 3008493238
- 3015525148
- 3006460162
- 2518422
- 3004415095
- 2080783
- 9615030
- 3016618143
- 3026585241
- 1528142
- 3006564498
- 3023744170
- 3019555519
- 2124215
- 3038294020
- 3007137598
- 3012164459
- 3006330030
- 3010331645
- 3012623144
- 3026007685
- 3012128418
- 3006993514
- 1220648
- 3006990600
- 3015529350
- 9610877
- 3005210579
- 3015185344
- 3030511423
- 3003782610
- 3004009431
- 1530224
- 3004604967
- 3004722076
- 3012784958
- 3042204971
- 3005545408
- 3013764800
- 3002806740
- 3027204138
- 3014730563
- 1529102
- 3002808157
- 2518897
- 3006498370
- 3008253300
- 3011230048
- 3015337348
Source Documents#
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases