510(k) K260250
- Device
- QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W)
- Applicant
- QT Medical, Inc.
- 510(k) number
- K260250
- Product code
- DPS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-09-29
- Date received
- 2026-01-27
- 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
- Irving Yu
- Address
- 1370 Valley Vista Dr. Suite 266 Diamond Bar CA US 91765 91765
FDA Registration Numbers#
- 3004145393
- 3030733800
- 3031158
- 1220908
- 9710602
- 3010838917
- 3034603279
- 3030446844
- 8030978
- 3003622639
- 3008820594
- 3013896610
- 3018587883
- 8030229
- 3007836437
- 3009183442
- 3014579161
- 3035371769
- 3008293988
- 3007413079
- 1066427
- 8030673
- 3013500228
- 3041276591
- 3011359729
- 3013501110
- 2000004234
- 3013557562
- 3016852448
- 3043226252
- 3021131596
- 3007734888
- 3009831876
- 3003174284
- 3003832357
- 3011353843
- 3007770164
- 1218950
- 1450057
- 1651104
- 3005569927
- 2182208
- 3003647588
- 3033959233
- 3008505660
- 3008164770
- 3003263092
- 3016674095
- 9611045
- 3014522540
- 3007048291
- 3005783425
- 2080783
- 3000130829
- 3007134734
- 3010157426
- 3004582233
- 3012404027
- 3045323923
- 9680510
- 3004415095
- 3043479346
- 3008729547
- 9611031
- 9610105
- 3029871637
- 3023272766
- 1930027
- 3012027770
- 1316463
- 3013689228
- 3042928308
- 1319390
- 3003971136
- 3013250653
- 3012528160
- 3016701404
- 3005877899
- 3007305624
- 8030245
Source Documents#
Other 510(k) Records For Product Code DPS#
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|---|---|---|---|
| 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 |
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| 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 |