510(k) K252463
- Device
- SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)
- Applicant
- Edan Instruments, Inc.
- 510(k) number
- K252463
- Product code
- DPS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-07-02
- Date received
- 2025-08-06
- 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
Applicant Contact#
- Contact
- Tracy Yue
- Address
- 15 Jinhui Rd., Jinsha Community, Kengzi Sub-District, Pingshan District, Shenzhen CN 518122 518122
FDA Registration Numbers#
- 3013557562
- 2024089
- 3003681187
- 3033959233
- 3015142815
- 3016931915
- 3013679558
- 3013757696
- 3010390468
- 2182208
- 1220477
- 3011861727
- 3008457078
- 3032109181
- 3001570235
- 9710602
- 3013298431
- 3004035727
- 3014848734
- 9611252
- 3009183442
- 3010082909
- 3018783526
- 3014522540
- 1523530
- 1930027
- 1000122786
- 3004186703
- 3030125003
- 3038472982
- 3018587883
- 3033536319
- 3009607734
- 3007184699
- 3016618143
- 3023146633
- 3010698831
- 3013501110
- 3003294644
- 3011235999
- 3009831876
- 3030639099
- 3007384703
- 3023412068
- 3004145393
- 3011200896
- 1054713
- 2433214
- 8030978
- 3008483389
- 3030154814
- 3010419931
- 3006371704
- 3013689228
- 3003857828
- 8030245
- 3009735945
- 3004415095
- 3007734888
- 3001149827
- 2084041
- 3012250536
- 3030733800
- 3001373226
- 1450057
- 3012359877
- 1218950
- 3005521864
- 3010536822
- 3016852448
- 3020981894
- 1066270
- 3043479346
- 3015134086
- 3031786139
- 1126271
- 3045323923
- 3013596024
- 3010157426
Source Documents#
Other 510(k) Records For Product Code DPS#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260005 | MyoVista wavECG (DG-200-B15-003) | HeartSciences, Inc. | 2026-10-05 |
| K260250 | QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W) | QT Medical, Inc. | 2026-09-29 |
| K254255 | S-Patch CardioAI | Wellysis Corp. | 2026-09-25 |
| K251670 | MAC 7 Resting ECG Analysis System | Ge Medical Systems Information Technologies, Inc. | 2026-01-26 |
| K252361 | AccurECG Analysis System (v2.0) | Accurkardia, Inc. | 2025-12-22 |
| 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 |