510(k) K252361
- Device
- AccurECG Analysis System (v2.0)
- Applicant
- Accurkardia, Inc.
- 510(k) number
- K252361
- Product code
- DPS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-12-22
- Date received
- 2025-07-29
- Regulation
- 870.2340
- Classification name
- Electrocardiograph
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Juan Jimenez
- Address
- 101 Ave. Of The Americas Suite 931 New York NY US 10013 10013
FDA Registration Numbers
- 3005877899
- 9710602
- 3023146633
- 1218950
- 3003174284
- 3032109181
- 1054713
- 3004145393
- 3006371704
- 3010342616
- 1066427
- 3008881835
- 3013188547
- 3016701404
- 3006087789
- 3009077524
- 3014522540
- 3030597723
- 2000004234
- 1450057
- 3030447506
- 3018783526
- 3010390468
- 3013557562
- 9617277
- 3008716327
- 3003294644
- 3011235999
- 8030229
- 3030125003
- 8030245
- 3007770164
- 3008164770
- 3007184699
- 3015142815
- 3012302888
- 3005569927
- 9615102
- 2080783
- 3030733800
- 3033536319
- 3010157426
- 3042928308
- 3020981894
- 3005488716
- 1066270
- 3007384703
- 3010097171
- 3007734888
- 2433214
- 3008729547
- 3012421607
- 3009183442
- 3013679558
- 3021422553
- 3011861727
- 3007413079
- 3016618143
- 3004035727
- 3012250536
- 3004186703
- 3008921101
- 3004906872
- 3014848734
- 3012528160
- 3004582233
- 3003832357
- 3021131596
- 3014579161
- 3000130829
- 3034603279
- 3003622639
- 3018587883
- 3015134086
- 3007048291
- 3010536822
- 3011200896
- 3007836437
- 3013896610
- 3033959233
- 3003591740
- 3013689228
- 3010082909
- 9611295
- 3014449259
- 3001570235
- 3008293988
- 3004415095
- 3008457078
- 9610816
- 1523530
- 3016931915
- 3003263092
- 3008642652
- 3000126629
- 9680510
- 3012516456
- 3030446844
- 3003857828
- 3011353843
- 3012494290
- 3003971136
- 3009443693
- 9610105
- 3019388613
- 3008820594
- 3021559257
- 3012404027
- 3031786139
- 1930027
- 3011359729
- 3029871637
- 3023412068
- 3012027770
- 3005783425
- 3008505660
- 1220477
- 3009735945
- 1219324
- 3030154814
- 3010698831
- 3013596024
- 3043479346
- 3023272766
- 1314417
- 2182208
- 1126271
- 1651104
- 1000122786
- 3003681187
- 3041276591
- 3005521864
- 3001373226
- 3006979678
- 3013501110
- 3032536454
- 8030978
- 3013250653
- 3036039911
- 3007029079
- 1316463
- 3008483389
- 3010419931
- 3013500228
- 3007134734
- 3001149827
- 3016674095
- 3011721071
- 1319390
- 3010089768
- 3009499478
- 1220908
- 3008717264
- 9611045
- 3010838917
- 3012359877
- 3014541700
- 3009715978
- 3016852448
- 3003647588
- 8030673
- 3009831876
- 9611252
- 3007305624
- 3031158
- 3038259592
- 3030639099
- 3018094310
- 3013757696
- 3009607734
- 3011651230
- 3033558564
- 2084041
- 3010381606
Source Documents
Other 510(k) Records For Product Code DPS
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251670 | MAC 7 Resting ECG Analysis System | Ge Medical Systems Information Technologies, Inc. | 2026-01-26 |
| K252474 | Withings BeamO (SCT02) | Withings | 2025-11-10 |
| K250569 | Cardiologs Holter Platform | Philips France Commercial | 2025-08-06 |
| K243252 | ZBPro Diagnostic | Zbeats, Inc. | 2025-07-10 |
| K243305 | Masimo W1 | Masimo Corporation | 2025-04-03 |
| K241217 | CloudHRV™ System (100-01-001) | Inmedix, Inc. | 2025-01-16 |
| K241556 | Cardiac Workstation (5000); Cardiac Workstation (7000) | Philips Medizin Systeme Böblingen GmbH | 2024-12-17 |
| K240229 | Masimo W1 | Masimo Corporation | 2024-08-08 |
| K232161 | DeepRhythm Platform | Medicalgorithmics S.A. | 2024-06-20 |
| K233266 | MEDIBLU ECG SYSTEM | Mediblu Medical, LLC | 2024-06-12 |
| K232035 | Impala | AliveCor, Inc. | 2024-06-07 |
| K232816 | Electrocardiograph, model: ECG301 | Shenzhen LE Medical Technology Co., Ltd. | 2024-06-07 |
| K232445 | CSF-4 (CSF-4) | Cardiacsense | 2024-05-02 |
| K232823 | MCG-S (AM1000) | Amcg Co., Ltd. | 2024-04-05 |
| K231160 | Cardio Q50, Cardio Q70 | Bionet Co., Ltd. | 2023-12-15 |