510(k) K240177
- Device
- Zio AT® device (A100A1001)
- Applicant
- iRhythm Technologies, Inc.
- 510(k) number
- K240177
- Product code
- DSI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-10-30
- Date received
- 2024-01-23
- Regulation
- 870.1025
- Classification name
- Detector And Alarm, Arrhythmia
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Soyini Hamit
- Address
- 699 8th St. Suite 600 San Francisco CA US 94103 94103
FDA Registration Numbers
- 3015181391
- 9710602
- 3007734888
- 2028530
- 3014541700
- 3008716327
- 3013501110
- 3019388613
- 3008363989
- 3010157426
- 3010112812
- 3013783488
- 3009883402
- 3004574071
- 2017865
- 1000425315
- 3009499478
- 3004977335
- 1066270
- 3012552532
- 3029904429
- 3010863450
- 3010698831
- 9681377
- 3018783526
- 3007208829
- 2182208
- 9611500
- 3013596024
- 3013500228
- 3010120148
- 1037137
- 3013679558
- 9610816
- 3010703925
- 3011120183
- 3021769057
- 3023164
- 3004009431
- 3022298579
- 3009673645
- 3016812424
- 3013791928
- 3009490946
- 3007836437
- 3005877899
- 3004188066
- 3008483389
- 3009380063
- 9611031
- 3016852448
- 3012606445
- 3009607734
- 1033601
- 3011937459
- 3003589956
- 3003263092
- 3007770164
- 3007413079
- 3007603826
- 3010082909
- 3008773647
- 3023272766
- 3009831876
- 3031162043
- 2133409
- 3004415095
- 3012359877
- 3004185781
- 9614453
- 1651104
- 3003971136
- 1316463
- 3012238587
- 3015328411
- 3009077524
- 3016618143
- 3010041430
- 3010381606
- 3010536822
Source Documents
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