510(k) K091513
- Device
- SMART ECG SERIES ELECTROCARDIOGRAPH, MODELS SE-3, SE-300A AND 300B, SE-6, SE-600, SE-12, SE-12 EXPRESS AND SE-1200
- Applicant
- EDAN INSTRUMENTS, INC.
- 510(k) number
- K091513
- Product code
- DPS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-07-24
- Date received
- 2009-05-22
- 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
- Yes
Applicant Contact#
- Contact
- WILLIAM STERN
- Address
- 1 Odell Plz. Yonkers NY US 10701 10701
FDA Registration Numbers#
- 8030978
- 3008717264
- 3013689228
- 3007134734
- 3030447506
- 3030597723
- 3020981894
- 3023412068
- 3013500228
- 3014848734
- 3000126629
- 3012528160
- 2084041
- 3010536822
- 3003647588
- 1054713
- 3007734888
- 3013250653
- 3001373226
- 3007029079
- 3016674095
- 3021422553
- 3013679558
- 9610105
- 3005569927
- 8030673
- 1066427
- 1314417
- 3013757696
- 3031570367
- 1000122786
- 2433214
- 3023272766
- 3012359877
- 3019388613
- 3011861727
- 3011200896
- 1523530
- 3021559257
- 3004145393
- 2000004234
- 3035371769
- 3008505660
- 1126271
- 3036039911
- 3043668257
- 3034603279
- 1930027
- 3003622639
- 3031158
- 3003971136
- 3016931915
- 3007384703
- 3018783526
- 9680510
- 1316463
- 3030125003
- 8030245
- 3018587883
- 3010097171
- 3007048291
- 3029871637
- 9615102
- 3032109181
- 3007184699
- 3010419931
- 9611045
- 3008716327
- 3009499478
- 9617277
- 3014541700
- 3011651230
- 3023146633
- 3012421607
- 3003857828
- 3004415095
- 3033558564
- 9710602
- 3003263092
Source Documents#
Other 510(k) Records For Product Code DPS #
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|---|---|---|---|
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| K252474 | Withings BeamO (SCT02) | Withings | 2025-11-10 |
| K250569 | Cardiologs Holter Platform | Philips France Commercial | 2025-08-06 |
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| K243305 | Masimo W1 | Masimo Corporation | 2025-04-03 |
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| 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 |
Legacy Summary#
summary
FDA Review#
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