K210560 is an FDA 510(k) clearance for the Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph. This device is classified as a Electrocardiograph (Class II - Special Controls, product code DPS).
Submitted by Philips Medical Systems (Shanghai, CN). The FDA issued a Cleared decision on June 30, 2021, 125 days after receiving the submission on February 25, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2340.
| 510(k) Number | K210560 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 25, 2021 |
| Decision Date | June 30, 2021 |
| Days to Decision | 125 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DPS — Electrocardiograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2340 |