510(k) K210753
- Device
- KardiaMobile 6L
- Applicant
- AliveCor, Inc.
- 510(k) number
- K210753
- Product code
- DPS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-06-30
- Date received
- 2021-03-15
- 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
- Saket Bhatt
- Address
- 444 Castro St. Suite 600 Mountain View CA US 94041 94041
FDA Registration Numbers#
- 3013689228
- 3011265784
- 3007208829
- 3000126629
- 3012528160
- 3003647588
- 3007734888
- 3013250653
- 3001373226
- 3021422553
- 9610105
- 3012359877
- 3019388613
- 2000004234
- 3006418479
- 3027815
- 3035371769
- 2133641
- 9680510
- 8030245
- 3010097171
- 3013681758
- 3013684844
- 3008881376
- 3032109181
- 3007184699
- 3010419931
- 9611045
- 9617277
- 3023146633
- 9710602
- 3015185344
- 3005737664
- 3010742884
- 3008293988
- 2182208
- 3008881835
- 3012516456
- 2017865
- 3010399798
- 3012404027
- 1450057
- 2028530
- 3010157426
- 3016618143
- 3013896610
- 3014522540
- 3021769057
- 3010082909
- 3006371704
- 3017942784
- 3012302888
- 3010363430
- 3011235999
- 1000425315
- 3011937459
- 3015976873
- 3000130829
- 3015134086
- 3010381606
- 3013164281
- 3013188547
- 3042928308
- 3003174284
- 1218950
- 3012267350
- 3014235520
- 9611295
- 3008820594
- 3008729547
- 3001149827
- 1527715
- 3018094310
- 3001570235
- 3014982325
- 3032536454
- 3009715978
- 3004035727
- 3017884848
- 3002808458
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 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases