The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Page Writer Tc20 Cardiograph, Page Writer Tc30 Cardiograph, Page Writer Tc50 Cardiograph, Page Writer Tc70 Cardiograph.
| Device ID | K210560 |
| 510k Number | K210560 |
| Device Name: | Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph |
| Classification | Electrocardiograph |
| Applicant | Philips Medical Systems Building A2, #718 Lingshi Road, Jingan District Shanghai, CN 200072 |
| Contact | Hong Zhu |
| Correspondent | Hong Zhu Philips Medical Systems Building A2, #718 Lingshi Road, Jingan District Shanghai, CN 200072 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-25 |
| Decision Date | 2021-06-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838107199 | K210560 | 000 |