K191738 is an FDA 510(k) clearance for the PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50 Cardiograph, PageWriter 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 September 29, 2020, 459 days after receiving the submission on June 28, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2340.
| 510(k) Number | K191738 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 28, 2019 |
| Decision Date | September 29, 2020 |
| Days to Decision | 459 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DPS — Electrocardiograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2340 |