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#
- 3013410552
- 3030597723
- 3015316279
- 3026007685
- 3007799743
- 3008787503
- 3014848734
- 3003647588
- 3014730563
- 3006990600
- 3026606276
- 3023272766
- 2024168
- 3027339877
- 2032227
- 3007697958
- 9615126
- 9615102
- 3002879653
- 3004415095
- 3003755939
- 3013429700
- 3029300449
- 3006503706
- 3011051075
- 3005900820
- 3037966017
- 3007573469
- 3013003882
- 3004722076
- 3011786259
- 3002579136
- 8030229
- 2919016
- 1219343
- 3013646951
- 9615010
- 3019793765
- 3013922904
- 3002725312
- 3009137498
- 9613959
- 3004185781
- 3021226419
- 3021336182
- 3004123209
- 3038206342
- 9611451
- 3014637079
- 8010273
- 3009711478
- 3007137598
- 9611102
- 3005210579
- 3009144084
- 3006680097
- 3003537036
- 3018094310
- 2134492
- 3013403214
- 3011353843
- 3015974593
- 3030265385
- 3016727307
- 8021774
- 3014004349
- 3009486782
- 3010813822
- 2086725
- 3030926959
- 3030089065
- 3003477135
- 3003587684
- 3013464458
- 3010258456
- 3039640904
- 3037000637
- 3015168097
- 2182207
Source Documents#
Legacy Summary#
summary
FDA Review#
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