K830566 is an FDA 510(k) clearance for the CONVERTER UNIT FOR ECG TRACE DISPLAY. This device is classified as a Electrocardiograph (Class II - Special Controls, product code DPS).
Submitted by Honeywell, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 25, 1983, 91 days after receiving the submission on February 23, 1983.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2340.
| 510(k) Number | K830566 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 23, 1983 |
| Decision Date | May 25, 1983 |
| Days to Decision | 91 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DPS — Electrocardiograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2340 |