510(k) K131000
- Device
- V-PATCH SYSTEM
- Applicant
- INTELESENS LIMITED
- 510(k) number
- K131000
- Product code
- DSI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-01-08
- Date received
- 2013-04-10
- 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
- PAUL DRYDEN
- Address
- 24301 Woodsage Dr. Bonita Springs FL US 34134 34134
FDA Registration Numbers#
- 3009490946
- 3003263092
- 3008773647
- 3007048291
- 3043543260
- 1651104
- 1219324
- 3010041430
- 3012528160
- 3004593495
- 8030229
- 3013501110
- 3017942784
- 3010082909
- 2028530
- 3003584029
- 3008363989
- 3005783425
- 3009156722
- 3006979678
- 3004188066
- 3016812424
- 3007836437
- 1833920
- 3016701404
- 3004977335
- 3008483389
- 3009883402
- 3011937459
- 3013500228
- 3012606445
- 3018783526
- 1000425315
- 3013889955
- 3004185781
- 3007603826
- 3010536822
- 3010381606
- 3007770164
- 3000126629
- 2133409
- 3007734888
- 3009831876
- 3032109181
- 3021769057
- 3007305624
- 3007208829
- 3016852448
- 3010032903
- 2017865
- 3023272766
- 2221819
- 3010112812
- 3031162043
- 2182208
- 9610816
- 3012359877
- 3016674095
- 3010120148
- 3005877899
- 3005737664
- 3008716327
- 1000122786
- 3010390468
- 3008729547
- 3013679558
- 3022298579
- 1037137
- 3023164
- 3015328411
- 1218950
- 3004009431
- 3009077524
- 3009380063
- 3009673645
- 9611500
- 1033601
- 3009959868
- 1316463
- 9610105
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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