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#
- 3004957206
- 3005739655
- 1066427
- 3016053964
- 3016499552
- 3004070020
- 3031823504
- 3017829091
- 3016670256
- 3043041722
- 2518897
- 3008101184
- 1220648
- 3043603319
- 3008493238
- 3017448360
- 3004832819
- 8010273
- 8043933
- 3015525148
- 3011051075
- 3038206342
- 3004123209
- 3010120339
- 8021774
- 3035371773
- 3014926240
- 2032227
- 8043629
- 3002579136
- 3003755939
- 3000279201
- 3002806740
- 3010972758
- 3045738115
- 3015328411
- 3026585241
- 1530224
- 3009632672
- 9615754
- 1422681
- 3003604053
- 3021071743
- 2024168
- 2183744
- 3019388613
- 3013646951
- 2518422
- 3013700547
- 3009711478
- 3026566521
- 3012164459
- 3023744170
- 3017092329
- 3006498370
- 3016727307
- 8020790
- 1226318
- 3009227717
- 3016701404
- 3001104093
- 3013059683
- 3016618143
- 3038356864
- 3006460162
- 3007573469
- 3015194289
- 9610877
- 3006503706
- 3015912984
- 3016851379
- 3009023553
- 3011230048
- 3003782610
- 3015534077
- 3018094310
- 1218950
- 3003998208
- 3027204138
Source Documents#
Legacy Summary#
summary
FDA Review#
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