510(k) K121628
- Device
- EPI MINI ECG PORTABLE HEALTH MONITORING SYSTEM (EPI MINI)
- Applicant
- EPI MOBILE HEALTH SOLUTIONS (S) PTE LTD
- 510(k) number
- K121628
- Product code
- DXH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-06-25
- Date received
- 2012-06-04
- Regulation
- 870.2920
- Classification name
- Transmitters And Receivers, Electrocardiograph, Telephone
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KARL M NOBERT
- Address
- 1200 19th St., NW Washington DC US 20032 20032
FDA Registration Numbers#
- 3013689228
- 3011265784
- 3007208829
- 3000126629
- 3012528160
- 3003647588
- 3007734888
- 3013250653
- 3001373226
- 3021422553
- 9610105
- 3012359877
- 3019388613
- 2000004234
- 3006418479
- 3027815
- 3035371769
- 2133641
- 9680510
- 8030245
- 3010097171
- 3013681758
- 3013684844
- 3008881376
- 3032109181
- 3007184699
- 3010419931
- 9611045
- 9617277
- 3023146633
- 9710602
- 3015185344
- 3005737664
- 3010742884
- 3008293988
- 2182208
- 3008881835
- 3012516456
- 2017865
- 3010399798
- 3012404027
- 1450057
- 2028530
- 3010157426
- 3016618143
- 3013896610
- 3014522540
- 3021769057
- 3010082909
- 3006371704
- 3017942784
- 3012302888
- 3010363430
- 3011235999
- 1000425315
- 3011937459
- 3015976873
- 3000130829
- 3015134086
- 3010381606
- 3013164281
- 3013188547
- 3042928308
- 3003174284
- 1218950
- 3012267350
- 3014235520
- 9611295
- 3008820594
- 3008729547
- 3001149827
- 1527715
- 3018094310
- 3001570235
- 3014982325
- 3032536454
- 3009715978
- 3004035727
- 3017884848
- 3002808458
Source Documents#
Other 510(k) Records For Product Code DXH #
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|---|---|---|---|
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| K250258 | HeartBeam AIMIGo with 12-L ECG Synthesis Software System | Heartbeam, Inc. | 2025-12-08 |
| K243438 | MEMO Patch M (MPT-E08R-UNC01) | Huinno Co., Ltd. | 2025-12-05 |
| K243981 | Hexoskin Medical System (7100-00016) | Carre Technologies, Inc. | 2025-11-18 |
| K243003 | VitalSigns 1-Lead Holter (VSH101) | VitalSigns Technology Co., Ltd. | 2025-06-17 |
| K233521 | QT ECG (QTERD100) | QT Medical, Inc. | 2023-12-06 |
| K222842 | V-Patch Cardiac Monitor | Shandong Corecare Technology Limited | 2022-10-20 |
| K220795 | QT ECG | QT Medical, Inc. | 2022-09-26 |
| K213357 | Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor | Verily Life Sciences, LLC | 2022-07-19 |
| K220350 | KardiaMobile 6L | AliveCor, Inc. | 2022-05-25 |
| K211668 | KardiaMobile Card | AliveCor, Inc. | 2021-11-30 |
| K212160 | SimpleSENSE Platform | Nanowear, Inc. | 2021-09-22 |
| K210753 | KardiaMobile 6L | AliveCor, Inc. | 2021-06-30 |
| K201669 | SimpleSENSE | Nanowear, Inc. | 2020-11-06 |
| K193296 | eCordum Cardiac Monitor (eCordum CM) | Ecordum, Inc. | 2020-10-30 |
Legacy Summary#
summary
FDA Review#
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