K031422 is an FDA 510(k) clearance for the PHILIPS PAGE WRITER TRIM SERIES CARDIOGRAPH INCLUDING I, II, III, MODELS 860286, 860287, 860288, 860289, 860290, 860291. This device is classified as a Electrocardiograph (Class II - Special Controls, product code DPS).
Submitted by Philips Medical Systems (Andover, US). The FDA issued a Cleared decision on July 3, 2003, 58 days after receiving the submission on May 6, 2003.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2340.
| 510(k) Number | K031422 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 06, 2003 |
| Decision Date | July 03, 2003 |
| Days to Decision | 58 days |
| Submission Type | Abbreviated |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DPS — Electrocardiograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2340 |