510(k) K103764
- Device
- REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529 AND REVEAL DX INSERTABLE CARDIAC MONITOR, MODEL 9528
- Applicant
- MEDTRONIC INC.
- 510(k) number
- K103764
- Product code
- DSI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-05-04
- Date received
- 2010-12-23
- 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
Applicant Contact#
- Contact
- YUKIKO CORSON
- Address
- 8200 Coral Sea St. N.E Mounds View MN US 55112 55112
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#
Other 510(k) Records For Product Code DSI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243349 | BodyGuardian Remote Monitoring System (BGRMS v3.0) | Boston Scientific Cardiac Diagnostic Technologies, Inc. | 2026-01-23 |
| K250356 | MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000) | Infobionic, Inc. | 2025-07-29 |
| K240177 | Zio AT® device (A100A1001) | iRhythm Technologies, Inc. | 2024-10-30 |
| K230265 | MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System | Infobionic, Inc. | 2023-10-06 |
| K231276 | SmartCardia 7L Platform | Smartcardia SA | 2023-08-30 |
| K193104 | Unified Arrhythmia Diagnostic System PocketECG IV | Medicalgorithmics S.A. | 2020-04-09 |
| K192732 | BodyGuardian Remote Monitoring System | Preventice Technologies, Inc. | 2020-03-26 |
| K190574 | Patient Assistant Model PA97000 | Medtronic, Inc. | 2019-09-24 |
| K182532 | Liba3 System | National Cardiac, Inc. | 2019-05-15 |
| K181658 | MobileECG 2 BT | Memtec Corporation | 2019-03-26 |
| K173969 | Medicalgorithmics Unified Cardiac Rehabilitation System | Medicalgorithmics S.A. | 2018-07-11 |
| K173170 | Epicardia Anywhere | Medicomp, Inc. | 2018-01-10 |
| K153473 | Braemar Telemetry Patch System | Braemar Manufacturing, LLC | 2016-07-22 |
| K153477 | EMMa Electronic Monitoring Management | Vitasystems GmbH | 2016-05-25 |
| K152701 | Matrix Mini ECG Monitor | Global Instrumentation, LLC | 2016-04-22 |
Legacy Summary#
summary
FDA Review#
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