510(k) K210140
- Device
- Electrocardiograph: SE-1202
- Applicant
- Edan Instruments, Inc
- 510(k) number
- K210140
- Product code
- DPS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-10-01
- Date received
- 2021-01-19
- 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
- No
Applicant Contact#
- Contact
- Ying Dai
- Address
- 15 Jinhui Rd., Jinsha Community, Kengzi Sub-District, Pingshan District, Shenzhen CN 518122 518122
FDA Registration Numbers#
- 3010097171
- 3033959233
- 3043668257
- 3013689228
- 3012421607
- 3003832357
- 3003263092
- 3013250653
- 3012302888
- 3011235999
- 3030446844
- 3030154814
- 3001373226
- 3031786139
- 3020981894
- 3013757696
- 3007048291
- 3033558564
- 3010089768
- 1651104
- 1219324
- 3003647588
- 3004145393
- 3012528160
- 3030597723
- 8030229
- 3008717264
- 3013501110
- 3010082909
- 3014449259
- 3043226252
- 3021422553
- 3030733800
- 3015142815
- 3011200896
- 3005783425
- 3005569927
- 3018587883
- 3008457078
- 3031570367
- 1054713
- 3003622639
- 3004035727
- 3006979678
- 9617277
- 8030245
- 3007836437
- 3012250536
- 3016701404
- 3021131596
- 3008505660
- 3001149827
- 3008483389
- 3013500228
- 3014579161
- 3012027770
- 3018783526
- 3006087789
- 3004186703
- 3010536822
- 3007184699
- 9611045
- 3010381606
- 3007770164
- 3000126629
- 3007734888
- 3007384703
- 3015134086
- 3042928308
- 3011861727
- 3003174284
- 3023146633
- 3009831876
- 3032109181
- 3014848734
- 3032536454
- 3007305624
- 3016852448
- 3012404027
Source Documents#
Other 510(k) Records For Product Code DPS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252463 | SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E) | Edan Instruments, Inc. | 2026-07-02 |
| 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 |
| K232816 | Electrocardiograph, model: ECG301 | Shenzhen LE Medical Technology Co., Ltd. | 2024-06-07 |
| K232445 | CSF-4 (CSF-4) | Cardiacsense | 2024-05-02 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases