510(k) K221260
- Device
- CSF-3
- Applicant
- Cardiacsense
- 510(k) number
- K221260
- Product code
- DPS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-01-06
- Date received
- 2022-05-02
- 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
Related Records
Applicant Contact
- Contact
- Benita Lanzer
- Address
- Leshem 6-8 North Industrial Park Caesarea IL
FDA Registration Numbers
- 9710602
- 3005488716
- 3004906872
- 3007734888
- 3042928308
- 3014541700
- 3008716327
- 3013501110
- 3019388613
- 3010157426
- 3009443693
- 2084041
- 3011861727
- 3003832357
- 3033536319
- 3001373226
- 3015134086
- 3009499478
- 1066270
- 3008505660
- 3033558564
- 3018094310
- 8030673
- 3010698831
- 3012302888
- 3003294644
- 3030154814
- 3018783526
- 9611295
- 3010089768
- 3030639099
- 3043479346
- 3003681187
- 3011651230
- 1523530
- 2182208
- 3010097171
- 3003591740
- 3013596024
- 3013500228
- 3012027770
- 3013188547
- 3013679558
- 9610816
- 1220477
- 3014848734
- 3014522540
- 9680510
- 3031786139
- 3011235999
- 3007029079
- 3031570367
- 3010419931
- 3007836437
- 3005877899
- 3008483389
- 3012250536
- 3013689228
- 3016852448
- 1126271
- 3009183442
- 3011359729
- 3009607734
- 8030245
- 3000130829
- 3004582233
- 8030978
- 3005521864
- 3008164770
- 3003263092
- 3007770164
- 3008293988
- 1450057
- 3008921101
- 3016931915
- 3012404027
- 3007413079
- 1220908
- 3010082909
Source Documents
Other 510(k) Records For Product Code DPS
| 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 |