510(k) K191738
- Device
- PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50 Cardiograph, PageWriter TC70 Cardiograph
- Applicant
- Philips Medical Systems
- 510(k) number
- K191738
- Product code
- DPS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-09-29
- Date received
- 2019-06-28
- 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
- Hong Zhu
- Address
- Bldg. A2, #718 Lingshi Rd., Jingan District Shanghai CN 200072 200072
FDA Registration Numbers#
- 2024089
- 8030978
- 3031570367
- 9611295
- 9611045
- 1450057
- 9610105
- 3010419931
- 3008457078
- 3033536319
- 3033959233
- 3013188547
- 3012404027
- 3010157426
- 3016931915
- 3008820594
- 1219324
- 1319390
- 3010097171
- 3005877899
- 3013501110
- 3003294644
- 3009715978
- 3010838917
- 3010381606
- 3010390468
- 3003647588
- 3023272766
- 3018587883
- 8030229
- 3007734888
- 1066427
- 3009183442
- 3013679558
- 3029871637
- 3004906872
- 3013250653
- 3006979678
- 3021422553
- 9611031
- 1066270
- 3018094310
- 3006087789
- 3008642652
- 3001373226
- 1314417
- 3021559257
- 9680510
- 3012250536
- 3003263092
- 3010082909
- 3007184699
- 3030733800
- 3043479346
- 3003622639
- 3013596024
- 3045498928
- 3041276591
- 3016852448
- 3014579161
- 3001149827
- 9610816
- 3000126629
- 3001570235
- 3003174284
- 3031158
- 3012027770
- 1220908
- 8030245
- 3008483389
- 1218950
- 3032536454
- 3005521864
- 3012516456
- 3012421607
- 3008716327
- 9710602
- 3015142815
- 3033558564
- 3008164770
Source Documents#
Other 510(k) Records For Product Code DPS#
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|---|---|---|---|
| K254255 | S-Patch CardioAI | Wellysis Corp. | 2026-09-25 |
| 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 |