K042628 is an FDA 510(k) clearance for the MODIFICATION TO: RADIANALYZER, MODEL 12711. This device is classified as a Computer, Diagnostic, Programmable (Class II - Special Controls, product code DQK).
Submitted by Radi Medical Systems AB (Uppsala, SE). The FDA issued a Cleared decision on January 19, 2005, 114 days after receiving the submission on September 27, 2004.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1425.
| 510(k) Number | K042628 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 2004 |
| Decision Date | January 19, 2005 |
| Days to Decision | 114 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 |