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-ane02 And L-ane02a Software.
| Device ID | K021279 |
| 510k Number | K021279 |
| Device Name: | DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANE02 AND L-ANE02A SOFTWARE |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | DATEX-OHMEDA 86 PILGRIM RD. Needham, MA 02492 |
| Contact | Joel C Kent |
| Correspondent | Joel C 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 | 2002-04-22 |
| Decision Date | 2002-07-19 |
| Summary: | summary |