510(k) K823529
- Device
- FULL-DISCLOSURE AMBULATORY ECG SYSTEM
- Applicant
- CLINICAL DATA, INC.
- 510(k) number
- K823529
- Product code
- DPS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-12-15
- Date received
- 1982-11-23
- Regulation
- 870.2340
- Classification name
- Electrocardiograph
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3011353843
- 3009077524
- 3008457078
- 3007134734
- 3014449259
- 3013757696
- 9680510
- 3008820594
- 8030229
- 3013250653
- 1220477
- 3006087789
- 3003647588
- 1218950
- 3012528160
- 3006979678
- 3013500228
- 3011235999
- 3032109181
- 3012027770
- 9610105
- 8030245
- 2084041
- 3011861727
- 3008716327
- 3014848734
- 3005783425
- 3012359877
- 3004415095
- 3013679558
- 3030125003
- 3003591740
- 3032536454
- 3005569927
- 3008293988
- 8030978
- 3007836437
- 3005877899
- 3007770164
- 3015134086
- 3003857828
- 3007413079
- 3004582233
- 3018094310
- 1066270
- 1930027
- 3014579161
- 3014541700
- 3014522540
- 3010342616
- 3029871637
- 3007184699
- 3013596024
- 3016674095
- 3016618143
- 3008483389
- 3010419931
- 3042928308
- 3015142815
- 3008729547
- 3000126629
- 9710602
- 3004906872
- 1220908
- 3007384703
- 2080783
- 3009735945
- 3041276591
- 3030447506
- 3033959233
- 1450057
- 3035371769
- 3010536822
- 3012516456
- 9611295
- 3011721071
- 3013689228
- 3012302888
- 1066427
- 9615102
Source Documents#
510(k) summary PDF not indicated by FDA
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