K080670 is an FDA 510(k) clearance for the MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM. This device is classified as a Computer, Blood-pressure (Class II - Special Controls, product code DSK).
Submitted by Atcor Medical (West Ryde Nsw, AU). The FDA issued a Cleared decision on April 23, 2008, 44 days after receiving the submission on March 10, 2008.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1110.
| 510(k) Number | K080670 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 10, 2008 |
| Decision Date | April 23, 2008 |
| Days to Decision | 44 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DSK - Computer, Blood-pressure |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1110 |