510(k) K212163
- Device
- Coala Heart Monitor
- Applicant
- Coala Life AB
- 510(k) number
- K212163
- Product code
- DPS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-04-14
- Date received
- 2021-07-12
- 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
- Dan Pitulia
- Address
- Kalsangsgrand 10b Uppsala SE 75319 75319
FDA Registration Numbers#
- 3032109181
- 9611045
- 3034603279
- 3012528160
- 3042928308
- 3009831876
- 3009443693
- 3000126629
- 2024089
- 3006087789
- 3013689228
- 9617277
- 3007384703
- 3030446844
- 9610816
- 3007836437
- 3005488716
- 3013501110
- 3001373226
- 1000122786
- 3008505660
- 3043668257
- 3007184699
- 3030154814
- 1066270
- 3045498928
- 3021559257
- 3043226252
- 3003591740
- 3030597723
- 3013679558
- 3041276591
- 3032536454
- 3003294644
- 3023146633
- 3003681187
- 8030978
- 1218950
- 3038472982
- 3007029079
- 1220477
- 3011200896
- 3013298431
- 9615102
- 3021131596
- 3007413079
- 3016674095
- 3030639099
- 3018783526
- 2084041
- 3023412068
- 3005521864
- 3008293988
- 3020981894
- 3033558564
- 3014449259
- 3003647588
- 3007305624
- 3038259592
- 9610105
- 3008642652
- 3009715978
- 9710602
- 3013896610
- 3008820594
- 3008881835
- 3004415095
- 3016852448
- 1930027
- 3014522540
- 3005877899
- 3013250653
- 3006979678
- 3010097171
- 3008716327
- 3011721071
- 3010089768
- 3009183442
- 1316463
- 3009077524
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#
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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