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#
- 3006503706
- 8043933
- 3035383301
- 3016851379
- 3009711478
- 9613959
- 2085602
- 9611451
- 3015802419
- 8010273
- 3007137598
- 3006990600
- 3043603319
- 3012128418
- 3003770140
- 3010363430
- 3020282963
- 3017435713
- 3013059683
- 3011353843
- 3013429700
- 3009486782
- 3010120339
- 1220648
- 2242863
- 3008505660
- 1825014
- 3021226419
- 3017233423
- 3004415095
- 3009555440
- 2520313
- 2183744
- 3014111150
- 3010331645
- 3027339877
- 9615010
- 3042025620
- 3027502949
- 8021774
- 9615754
- 9615102
- 3011466827
- 3027557334
- 3015337348
- 9614952
- 2024168
- 1722028
- 3021393544
- 3010342382
- 3039640904
- 3004957206
- 3013922904
- 3015077548
- 9610877
- 3010258456
- 3030926959
- 3008921101
- 3018783526
- 3003477135
- 3042366036
- 3011383638
- 2183449
- 3010000450
- 3017092329
- 3015200693
- 3017448360
- 3012883081
- 3044089019
- 3008699634
- 3013528571
- 3003630693
- 3037641416
- 3021336182
- 3003616071
- 3004167969
- 3013718526
- 3004070020
- 3007799743
Source Documents#
Legacy Summary#
summary
FDA Review#
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