K060167 is an FDA 510(k) clearance for the ATRIA 3100, ATRIA 6100. This device is classified as a Electrocardiograph (Class II - Special Controls, product code DPS).
Submitted by Cardiac Science Corporation (Bothell, US). The FDA issued a Cleared decision on April 19, 2006, 86 days after receiving the submission on January 23, 2006.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2340.
| 510(k) Number | K060167 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 23, 2006 |
| Decision Date | April 19, 2006 |
| Days to Decision | 86 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 |