The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Datex-ohmeda S/5 Anesthesia Monitor With L-aneo5 And L-aneo5a Software, Using F-cu8 Or F-cu5(p) Monitor Frame Options.
| Device ID | K051400 |
| 510k Number | K051400 |
| Device Name: | DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANEO5 AND L-ANEO5A SOFTWARE, USING F-CU8 OR F-CU5(P) MONITOR FRAME OPTIONS |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | GE HEALTHCARE 86 PILGRIM ROAD Needham, MA 02492 |
| Contact | Joel C Kent |
| Correspondent | Joel C Kent GE HEALTHCARE 86 PILGRIM ROAD Needham, MA 02492 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-31 |
| Decision Date | 2006-01-20 |
| Summary: | summary |