510(k) K250258
- Device
- HeartBeam AIMIGo with 12-L ECG Synthesis Software System
- Applicant
- Heartbeam, Inc.
- 510(k) number
- K250258
- Product code
- DXH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-12-08
- Date received
- 2025-01-28
- 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
- N
Applicant Contact#
- Contact
- Deborah Castillo
- Address
- 2118 Walsh Rd., Suite 210 Santa Clara CA US 95110 95110
FDA Registration Numbers#
- 9710602
- 3007734888
- 2028530
- 3042928308
- 3019388613
- 3015185344
- 3010157426
- 2017865
- 1000425315
- 3001373226
- 3015134086
- 3018094310
- 3012302888
- 3012267350
- 9611295
- 3007208829
- 2182208
- 2133641
- 3010097171
- 3013188547
- 3013164281
- 3014522540
- 3021769057
- 9680510
- 3011235999
- 3010419931
- 3013684844
- 3013689228
- 3006418479
- 8030245
- 3011937459
- 3008881376
- 3000130829
- 3008293988
- 1450057
- 3014982325
- 3012404027
- 3017884848
- 3010082909
- 3007184699
- 3008820594
- 3006371704
- 3008881835
- 3012359877
- 3001149827
- 3016618143
- 3010381606
- 3010742884
- 3015976873
- 1218950
- 3011265784
- 3010399798
- 1527715
- 3013250653
- 3027815
- 3032109181
- 3000126629
- 3009715978
- 3003174284
- 3002808458
- 3012528160
- 3014235520
- 3001570235
- 3021422553
- 3035371769
- 2000004234
- 3013681758
- 3010363430
- 3013896610
- 9617277
- 3004035727
- 3005737664
- 3017942784
- 9611045
- 3023146633
- 3003647588
- 3008729547
- 9610105
- 3012516456
- 3032536454
Source Documents#
Other 510(k) Records For Product Code DXH#
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| K210753 | KardiaMobile 6L | AliveCor, Inc. | 2021-06-30 |
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| K193296 | eCordum Cardiac Monitor (eCordum CM) | Ecordum, Inc. | 2020-10-30 |
| K201208 | Halo AF Detection System | Livmor | 2020-09-23 |