The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Datex-ohmeda S/5 Critical Care Monitor With L-icu05 And L-icu05a Software.
| Device ID | K071889 |
| 510k Number | K071889 |
| Device Name: | DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU05 AND L-ICU05A SOFTWARE |
| Classification | Detector And Alarm, Arrhythmia |
| 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 | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-09 |
| Decision Date | 2008-05-19 |
| Summary: | summary |