The following data is part of a premarket notification filed by Ge Healthcare Finland Oy with the FDA for Datex-ohmeda S/5 Anesthesia Monitor With L-aneo7 And L-aneo7a Software Using F-cu8 Or F-cu5 (p) Monitor Frame Options An.
| Device ID | K092680 |
| 510k Number | K092680 |
| Device Name: | DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANEO7 AND L-ANEO7A SOFTWARE USING F-CU8 OR F-CU5 (P) MONITOR FRAME OPTIONS AN |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | GE HEALTHCARE FINLAND OY KUORTANEENKATU 2 Helsinki, FI Fin-00510 |
| Contact | Rauno Ruoho |
| Correspondent | Rauno Ruoho GE HEALTHCARE FINLAND OY KUORTANEENKATU 2 Helsinki, FI Fin-00510 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-01 |
| Decision Date | 2009-09-23 |
| Summary: | summary |