The following data is part of a premarket notification filed by Ge Healthcare Finland Oy with the FDA for Carescape Respiratory Modules, E-sco, E-scov, E-scaiov And Accessories.
| Device ID | K123195 |
| 510k Number | K123195 |
| Device Name: | CARESCAPE RESPIRATORY MODULES, E-SCO, E-SCOV, E-SCAIOV AND ACCESSORIES |
| Classification | Analyzer, Gas, Oxygen, Gaseous-phase |
| Applicant | GE HEALTHCARE FINLAND OY KUORTANEENKATU 2 Helsinki, FI Fin-00510 |
| Contact | Rauno Ruoho |
| Correspondent | Rauno Ruoho GE HEALTHCARE FINLAND OY KUORTANEENKATU 2 Helsinki, FI Fin-00510 |
| Product Code | CCL |
| CFR Regulation Number | 868.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-11 |
| Decision Date | 2013-02-28 |
| Summary: | summary |