Product code DPS
- Device name
- Electrocardiograph
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.2340
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K232823 | MCG-S (AM1000) | Amcg Co., Ltd. | 2024-04-05 |
| K231160 | Cardio Q50, Cardio Q70 | Bionet Co., Ltd. | 2023-12-15 |
| K230834 | CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H | Trismed Co., Ltd. | 2023-11-21 |
| K232974 | EKGenius Smart System | Ekgenius, LLC | 2023-11-17 |
| K232512 | Masimo W1 | Masimo Corporation | 2023-11-17 |
| K231150 | Cardio P1 | Bionet Co., Ltd. | 2023-11-09 |
| K230812 | Withings Scan Monitor 2.0 | Withings | 2023-08-23 |
| K223670 | MESI mTablet ECG Diagnostic System, MESI mTablet ECG | Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O. | 2023-07-28 |
| K222902 | Electrocardiograph: SE-1200 Pro and SE-1201 Pro | Edan Instruments, Inc. | 2023-07-28 |
| K223013 | AccurECG Analysis System | Accurkardia, Inc. | 2023-06-23 |
| K221260 | CSF-3 | Cardiacsense | 2023-01-06 |
| K221141 | PageWriter TC35 Cardiograph | Medizin Systeme Boblingen GmbH | 2022-12-02 |
| K220535 | Cardio10 | Bionet Co., Ltd. | 2022-11-15 |
| K221321 | MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System | Ge Medical Systems Information Technologies, Inc. | 2022-10-18 |
| K212163 | Coala Heart Monitor | Coala Life AB | 2022-04-14 |
| K212278 | Electrocardiograph | Edan Instruments, Inc. | 2022-04-07 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| B3944670047010 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700068020 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700064010 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700063010 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700051020 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700048100 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700048090 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700048080 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700048070 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700048060 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700048050 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700048030 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3944060056010 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945000030010 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945300046010 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945300054010 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945300054020 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945600013020 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700048010 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700048020 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| B3945700048040 | WVSM Pro, Wireless Vital Signs Monitor Professional | ATHENA GTX, INC. | 2026-05-27 |
| G466CUSB0 | CardioCard | NASIFF ASSOCIATES INC | 2023-03-17 |
| 08809276940285 | CardioXP | Bionet CO,LTD | 2021-07-15 |
| 08809276943538 | CardioCare2000 | Bionet CO,LTD | 2021-07-15 |
| 08809276943545 | CardioTouch3000 | Bionet CO,LTD | 2021-07-15 |
| 08809276943552 | Cardio7 | Bionet CO,LTD | 2021-07-15 |
| 07613365000467 | Diagnostic Station DS20 | Schiller AG | 2016-09-19 |
| 07613365000474 | Diagnostic Station DS20 | Schiller AG | 2016-09-19 |
| 07613365000481 | Diagnostic Station DS20 | Schiller AG | 2016-09-19 |
| 07613365000498 | Diagnostic Station DS20 | Schiller AG | 2016-09-19 |