510(k) K252474
- Device
- Withings BeamO (SCT02)
- Applicant
- Withings
- 510(k) number
- K252474
- Product code
- DPS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-11-10
- Date received
- 2025-08-06
- 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
Related Records
Applicant Contact
- Contact
- Aline Criton
- Address
- 2 Rue Maurice Hartmann Issy-Les-Moulineaux FR 92130 92130
FDA Registration Numbers
- 3005877899
- 9710602
- 3023146633
- 1218950
- 3003174284
- 3032109181
- 1054713
- 3004145393
- 3006371704
- 3010342616
- 1066427
- 3008881835
- 3013188547
- 3016701404
- 3006087789
- 3009077524
- 3014522540
- 3030597723
- 2000004234
- 1450057
- 3030447506
- 3018783526
- 3010390468
- 3013557562
- 9617277
- 3008716327
- 3003294644
- 3011235999
- 8030229
- 3030125003
- 8030245
- 3007770164
- 3008164770
- 3007184699
- 3015142815
- 3012302888
- 3005569927
- 9615102
- 2080783
- 3030733800
- 3033536319
- 3010157426
- 3042928308
- 3020981894
- 3005488716
- 1066270
- 3007384703
- 3010097171
- 3007734888
- 2433214
- 3008729547
- 3012421607
- 3009183442
- 3013679558
- 3021422553
- 3011861727
- 3007413079
- 3016618143
- 3004035727
- 3012250536
- 3004186703
- 3008921101
- 3004906872
- 3014848734
- 3012528160
- 3004582233
- 3003832357
- 3021131596
- 3014579161
- 3000130829
- 3034603279
- 3003622639
- 3018587883
- 3015134086
- 3007048291
- 3010536822
- 3011200896
- 3007836437
- 3013896610
Source Documents
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| 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 |