The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Datex-ohmeda S/5 Cardiac Output And Svo2 Module, E-copsv And Accessories.
| Device ID | K052977 |
| 510k Number | K052977 |
| Device Name: | DATEX-OHMEDA S/5 CARDIAC OUTPUT AND SVO2 MODULE, E-COPSV AND ACCESSORIES |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | GE HEALTHCARE 86 PILGRIM ROAD Needham, MA 02492 |
| Contact | Joel Kent |
| Correspondent | Joel Kent GE HEALTHCARE 86 PILGRIM ROAD Needham, MA 02492 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-24 |
| Decision Date | 2005-11-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682104098 | K052977 | 000 |