K103678 is an FDA 510(k) clearance for the CASE CARDIAC TESTING SYSTEM, CS CARDIAC TESTING SYSTEM. This device is classified as a Computer, Diagnostic, Programmable (Class II - Special Controls, product code DQK).
Submitted by Ge Medical Systems Information Technologies GmbH (Freiburg,Baden Wurttemberg, DE). The FDA issued a Cleared decision on February 16, 2011, 62 days after receiving the submission on December 16, 2010.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1425.
| 510(k) Number | K103678 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 16, 2010 |
| Decision Date | February 16, 2011 |
| Days to Decision | 62 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQK - Computer, Diagnostic, Programmable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1425 |