510(k) K052511
- Device
- CARDIOFAX CE, MODEL ECG-1500 A
- Applicant
- NIHON KOHDEN AMERICA, INC.
- 510(k) number
- K052511
- Product code
- DPS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-05-24
- Date received
- 2005-09-14
- 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
- SERRAH NAMINI
- Address
- 90 Icon St. Foothill CA US 92610 92610
FDA Registration Numbers#
- 3008457078
- 3003174284
- 3010698831
- 3010390468
- 3008483389
- 3011861727
- 9710602
- 1218950
- 3007134734
- 3011235999
- 3008921101
- 3005488716
- 3009715978
- 3011651230
- 9611031
- 3003647588
- 3007184699
- 3008716327
- 1314417
- 8030978
- 2433214
- 3004906872
- 8030245
- 3008729547
- 3003591740
- 3007734888
- 3016852448
- 1930027
- 3030597723
- 1066427
- 1066270
- 3029871637
- 3004145393
- 3008164770
- 1220908
- 3013896610
- 3010089768
- 3030639099
- 3001373226
- 3012516456
- 9680510
- 3011200896
- 3018783526
- 3016674095
- 3042928308
- 3003622639
- 3031570367
- 3003857828
- 3007770164
- 3005569927
- 3009443693
- 3008820594
- 9610816
- 8030229
- 3012528160
- 2084041
- 3008642652
- 3032536454
- 9611295
- 3013689228
- 3008293988
- 3019388613
- 3007029079
- 8030673
- 9611045
- 3034603279
- 3023412068
- 3035371769
- 3015142815
- 3014522540
- 2182208
- 3033558564
- 3013757696
- 3012302888
- 3009183442
- 1219324
- 3004186703
- 3000130829
- 3009077524
- 3014848734
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 |
Legacy Summary#
summary
FDA Review#
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