K080461 is an FDA 510(k) clearance for the STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0. This device is classified as a Monitor, St Segment With Alarm (Class II - Special Controls, product code MLD).
Submitted by Philips Medical Systems (Andover, US). The FDA issued a Cleared decision on March 13, 2008, 22 days after receiving the submission on February 20, 2008.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K080461 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 20, 2008 |
| Decision Date | March 13, 2008 |
| Days to Decision | 22 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MLD — Monitor, St Segment With Alarm |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1025 |