K050074 is an FDA 510(k) clearance for the 12-LEAD RESTING ELECTROCARDIOGRAPH, MODELS CP100 & CP200. This device is classified as a Electrocardiograph (Class II - Special Controls, product code DPS).
Submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on March 22, 2005, 69 days after receiving the submission on January 12, 2005.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2340.
| 510(k) Number | K050074 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 12, 2005 |
| Decision Date | March 22, 2005 |
| Days to Decision | 69 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 |