GE Healthcare · Class II · Cleared Nov 22, 2005
| K-number | K052977 |
| Device name | DATEX-OHMEDA S/5 CARDIAC OUTPUT AND SVO2 MODULE, E-COPSV AND ACCESSORIES |
| Applicant | GE Healthcare |
| Product code | DQK |
| Device class | Class II |
| Decision date | Nov 22, 2005 |
| Decision | Substantially Equivalent |
| Regulation | 870.1425 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov