K131573 is an FDA 510(k) clearance for the CP150 ELECTROCARDIOGRAPH. 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 July 3, 2013, 34 days after receiving the submission on May 30, 2013.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2340.
| 510(k) Number | K131573 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 30, 2013 |
| Decision Date | July 03, 2013 |
| Days to Decision | 34 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DPS — Electrocardiograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2340 |