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#
- 3015134086
- 3007799743
- 8043933
- 3012250536
- 3019793765
- 3027605722
- 3017435713
- 3010120339
- 3014637079
- 2183449
- 3004363352
- 9680625
- 2024168
- 1825014
- 3020282963
- 3031158
- 3011466827
- 3015802419
- 3016851379
- 1119779
- 2032227
- 3004009431
- 3007697958
- 3010363430
- 3034603598
- 3014945378
- 3006615210
- 3030926959
- 3015912984
- 3015337348
- 3030089065
- 3008253300
- 3043479346
- 2518897
- 2124215
- 3009715978
- 3005545408
- 3015168097
- 3002579136
- 2954323
- 3009555440
- 3005755367
- 1721964
- 3017812398
- 3010972758
- 3021038030
- 3009632672
- 3027339877
- 3009137498
- 3016701404
- 3002806740
- 3004722076
- 8030229
- 2184007
- 3014730563
- 3019555519
- 3009144084
- 3043603319
- 3006498370
- 3038294020
- 3016670256
- 3014848734
- 3015194289
- 3012164459
- 3021393544
- 3013896610
- 2919016
- 1217183
- 2134492
- 3010960914
- 1220648
- 3015200693
- 3010227033
- 3007573469
- 3017829091
- 3006330030
- 3007220521
- 3008493238
- 2183744
Source Documents#
Legacy Summary#
summary
FDA Review#
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