510(k) K210560
- Device
- Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph
- Applicant
- Philips Medical Systems
- 510(k) number
- K210560
- Product code
- DPS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-06-30
- Date received
- 2021-02-25
- Regulation
- 870.2340
- Classification name
- Electrocardiograph
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Hong Zhu
- Address
- Bldg. A2, #718 Lingshi Rd., Jingan District Shanghai CN 200072 200072
FDA Registration Numbers#
- 9680510
- 3012421607
- 3008293988
- 3030125003
- 3007029079
- 3008717264
- 3014522540
- 3009183442
- 3015134086
- 3030154814
- 3013689228
- 3016852448
- 3012359877
- 3003263092
- 3012250536
- 3013188547
- 3016931915
- 3000130829
- 3007184699
- 3007734888
- 3009499478
- 3005521864
- 3016674095
- 2182208
- 3030447506
- 1930027
- 8030245
- 3012516456
- 8030673
- 3042928308
- 1319390
- 3001149827
- 3007413079
- 1000122786
- 3010419931
- 9617277
- 3010381606
- 2433214
- 3031158
- 3019388613
- 3010342616
- 3003647588
- 3014579161
- 3008881835
- 9610816
- 3012404027
- 3005783425
- 3003591740
- 3003174284
- 3010838917
- 3012528160
- 3010698831
- 3038259592
- 3036039911
- 9611295
- 3030733800
- 1220477
- 3010536822
- 3003681187
- 1054713
- 3007134734
- 3031786139
- 3043668257
- 3010082909
- 3009735945
- 3006087789
- 3021559257
- 3006979678
- 3003622639
- 3003294644
- 3003832357
- 3007836437
- 3008921101
- 3013557562
- 3033536319
- 1219324
- 3008820594
- 3009077524
- 1651104
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