K032103 is an FDA 510(k) clearance for the PHILIPS TRACEMASTER ECG MANAGEMENT SYSTEM, MODELS M5100A AND M5101A. This device is classified as a Recorder, Magnetic Tape, Medical (Class II - Special Controls, product code DSH).
Submitted by Philips Medical Systems (Andover, US). The FDA issued a Cleared decision on July 22, 2003, 14 days after receiving the submission on July 8, 2003.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2800.
| 510(k) Number | K032103 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 08, 2003 |
| Decision Date | July 22, 2003 |
| Days to Decision | 14 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DSH — Recorder, Magnetic Tape, Medical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2800 |