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 |
|---|---|---|---|
| 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 |
| 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 |
| 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 |
| K232512 | Masimo W1 | Masimo Corporation | 2023-11-17 |
| K232974 | EKGenius Smart System | Ekgenius, LLC | 2023-11-17 |
| K231150 | Cardio P1 | Bionet Co., Ltd. | 2023-11-09 |
| K230812 | Withings Scan Monitor 2.0 | Withings | 2023-08-23 |
| K222902 | Electrocardiograph: SE-1200 Pro and SE-1201 Pro | Edan Instruments, Inc. | 2023-07-28 |
| K223670 | MESI mTablet ECG Diagnostic System, MESI mTablet ECG | Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O. | 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 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00860011800613 | CardioTag | CARDIOSENSE, INC. | 2026-10-14 |
| 00195278840202 | MAC | Ge Medical Systems Information Technologies, Inc. | 2026-10-13 |
| 00195278949769 | TruSignal SpO2 MM 1.8M | GE Healthcare Finland Oy | 2026-10-04 |
| 00198953002186 | Carescape Dock F0 | GE Healthcare Finland Oy | 2026-10-04 |
| 00198953009567 | Carescape ONE | GE Healthcare Finland Oy | 2026-10-04 |
| 00195278949752 | TruSignal SpO2 MM 3.0M | GE Healthcare Finland Oy | 2026-10-04 |
| 00810209880118 | CORE 500 Digital Stethoscope - Lilac Chestpiece | Eko Health, Inc. | 2026-10-01 |
| 00810209880163 | CORE 500 Digital Stethoscope FIGS Earpiece - Espresso | Eko Health, Inc. | 2026-10-01 |
| 00810209880170 | CORE 500 Digital Stethoscope FIGS Earpiece - Ruby Red | Eko Health, Inc. | 2026-10-01 |
| 00810209880187 | CORE 500 Digital Stethoscope - Ember Chestpiece | Eko Health, Inc. | 2026-10-01 |
| 00810209880064 | CORE 500 Digital Stethoscope - Military Green Earpiece | Eko Health, Inc. | 2026-06-12 |
| 00810209880088 | CORE 500 Digital Stethoscope - Military Green Bundle | Eko Health, Inc. | 2026-06-12 |
| 00810209880071 | CORE 500 Digital Stethoscope - Navy Blue Bundle | Eko Health, Inc. | 2026-06-12 |
| 00810209880057 | CORE 500 Digital Stethoscope - Navy Blue Earpiece | Eko Health, Inc. | 2026-06-12 |
| 00810209880026 | CORE 500 Digital Stethoscope FIGS Earpiece - Orange Taffy | Eko Health, Inc. | 2026-04-03 |
| 00810209880019 | CORE 500 Digital Stethoscope FIGS Earpiece - Rapid Response Pink | Eko Health, Inc. | 2026-04-03 |
| 00810209880040 | EFAST (Eko Foundation Analysis Software with Transformers) | Eko Health, Inc. | 2026-01-29 |
| 00810209880002 | CORE 500 Digital Stethoscope FIGS Earpiece - Caribbean Blue | Eko Health, Inc. | 2026-01-29 |
| 00850010298245 | CORE 500 Digital Stethoscope FIGS Earpiece - Black | Eko Health, Inc. | 2025-03-18 |
| 00850010298252 | CORE 500 Digital Stethoscope FIGS Earpiece - Grey | Eko Health, Inc. | 2025-03-18 |
| 00850010298269 | CORE 500 Digital Stethoscope FIGS Earpiece - Mauve | Eko Health, Inc. | 2025-03-18 |
| 00850010298276 | CORE 500 Digital Stethoscope FIGS Earpiece - Sandstone | Eko Health, Inc. | 2025-03-18 |
| 00850010298184 | EMAS (Eko Murmur Analysis Software) | Eko Health, Inc. | 2025-03-17 |
| 00850010298283 | CORE 500 Digital Stethoscope - Black Chestpiece | Eko Health, Inc. | 2025-03-12 |
| 00850010298160 | Eko CORE 500 Digital Stethoscope Chestpiece | Eko Health, Inc. | 2023-07-10 |
| 00850010298177 | Eko CORE 500 Digital Stethoscope Earpiece | Eko Health, Inc. | 2023-07-10 |
| 00850010298191 | Eko CORE 500 and CAC500 Standard bundle | Eko Health, Inc. | 2023-07-10 |
| 00850010298207 | Eko CORE 500 and CAC500 Founder's Edition bundle | Eko Health, Inc. | 2023-07-10 |
| 00850010298214 | Eko CORE 500 Founder's Edition Chestpiece | Eko Health, Inc. | 2023-07-10 |
| 00850010298030 | Eko Analysis Software | Eko Health, Inc. | 2020-09-08 |