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-scovx, E-scaio, E-scaiov, E-scaiovx And Accessories.
| Device ID | K171028 |
| 510k Number | K171028 |
| Device Name: | CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX And Accessories |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | GE Healthcare Finland OY Kuortaneenkatu 2 Helsinki, FI Fi-00510 |
| Contact | Anna Pehrsson |
| Correspondent | Anna Pehrsson GE Healthcare Finland OY Kuortaneenkatu 2 Helsinki, FI Fi-00510 |
| Product Code | CCK |
| Subsequent Product Code | BZK |
| Subsequent Product Code | BZL |
| Subsequent Product Code | CAP |
| Subsequent Product Code | CBQ |
| Subsequent Product Code | CBR |
| Subsequent Product Code | CBS |
| Subsequent Product Code | CCL |
| Subsequent Product Code | NHO |
| Subsequent Product Code | NHP |
| Subsequent Product Code | NHQ |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-05 |
| Decision Date | 2017-08-17 |
| Summary: | summary |