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#
- 3014428919
- 3044827674
- 1320150
- 8010273
- 2518897
- 3003537036
- 3009227717
- 3037641416
- 9710051
- 3013896610
- 9617474
- 3021336182
- 9610877
- 3011230048
- 3014848734
- 3004091281
- 9610816
- 3030511423
- 3003971136
- 3014926240
- 2080783
- 3010716438
- 1220648
- 3015525148
- 3006503706
- 3010392999
- 8043629
- 2020676
- 3003755939
- 3004185781
- 3007573469
- 3026566521
- 3017233423
- 3018783526
- 3043603319
- 3003084417
- 3038206342
- 3017697442
- 3027339877
- 3009607734
- 3004945409
- 3008101184
- 2183646
- 3039640904
- 3044089019
- 3010331645
- 3017845286
- 1219343
- 3003604053
- 3012528160
- 3000279201
- 2919016
- 3042204971
- 3017812398
- 3007697958
- 3004167969
- 3015185344
- 3016670256
- 3012250536
- 8010177
- 3011383638
- 1000227151
- 2936999
- 2085602
- 3014004349
- 3015912984
- 3010972758
- 9611252
- 1523530
- 3016499552
- 3007799743
- 3002579136
- 3027502949
- 1530224
- 3006993514
- 9614446
- 8021774
- 1721964
- 3003477135
Source Documents#
Legacy Summary#
summary
FDA Review#
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