The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for St/ar St And Arrhythmia Software Model: Release K.o.
| Device ID | K101521 |
| 510k Number | K101521 |
| Device Name: | ST/AR ST AND ARRHYTHMIA SOFTWARE MODEL: RELEASE K.O |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN ROAD, MS 0480 Andover, MA 01810 |
| Contact | Lois Giegerich |
| Correspondent | Lois Giegerich PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN ROAD, MS 0480 Andover, MA 01810 |
| Product Code | MHX |
| Subsequent Product Code | DSI |
| Subsequent Product Code | MLD |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-02 |
| Decision Date | 2010-07-29 |
| Summary: | summary |