The following data is part of a premarket notification filed by Datex-ohmeda with the FDA for Datex-ohmeda S/5 Anesthesia Monitor With L-an03 And L-ane03a Software.
| Device ID | K030812 |
| 510k Number | K030812 |
| Device Name: | DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-AN03 AND L-ANE03A SOFTWARE |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | DATEX-OHMEDA 86 PILGRIM RD. Needham, MA 02492 |
| Contact | Joel Kent |
| Correspondent | Joel Kent DATEX-OHMEDA 86 PILGRIM RD. Needham, MA 02492 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-14 |
| Decision Date | 2003-05-21 |
| Summary: | summary |