510(k) K231150
- Device
- Cardio P1
- Applicant
- Bionet Co., Ltd.
- 510(k) number
- K231150
- Product code
- DPS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-11-09
- Date received
- 2023-04-21
- 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
- Kyungeun Park
- Address
- 5f, 61 Digital-Ro 31 Gil, Guro-Gu Seoul KR 08375 08375
FDA Registration Numbers#
- 3007134734
- 3019388613
- 3042928308
- 3004906872
- 3008881835
- 3003681187
- 1066270
- 3030446844
- 3012516456
- 2084041
- 9611295
- 1220477
- 3012421607
- 3045323923
- 3000130829
- 1450057
- 3010097171
- 3008505660
- 3004186703
- 3041276591
- 3043226252
- 3013557562
- 9611252
- 8030978
- 3012359877
- 2433214
- 3003647588
- 3008293988
- 3029871637
- 3030639099
- 3012302888
- 3033959233
- 3007305624
- 1314417
- 3008820594
- 3011651230
- 1316463
- 3030597723
- 3014522540
- 1054713
- 1126271
- 3011861727
- 1218950
- 3023272766
- 3031570367
- 1930027
- 3005783425
- 3013188547
- 3023412068
- 3010536822
- 3010419931
- 1219324
- 3005569927
- 3003174284
- 1523530
- 3030733800
- 3012528160
- 3033558564
- 3014541700
- 3007770164
- 3007413079
- 3001373226
- 3021422553
- 3011235999
- 9680510
- 3034603279
- 3011359729
- 3030447506
- 3001570235
- 3012027770
- 3031786139
- 3007734888
- 3007048291
- 3003857828
- 2000004234
- 1066427
- 3015134086
- 3003591740
- 3021559257
- 3015142815
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 |