The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Star St And Arrhythmia Software, Release J.0.
| Device ID | K080461 |
| 510k Number | K080461 |
| Device Name: | STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0 |
| Classification | Monitor, St Segment With Alarm |
| Applicant | PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
| Contact | Zety Billard |
| Correspondent | Zety Billard PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
| Product Code | MLD |
| Subsequent Product Code | DSI |
| Subsequent Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-20 |
| Decision Date | 2008-03-13 |
| Summary: | summary |