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, E-scaioe, E-scaiove And Accessories.
| Device ID | K211171 |
| 510k Number | K211171 |
| Device Name: | CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE And Accessories |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | GE Healthcare Finland Oy Kuortaneenkatu 2 Helsinki, FI Fi-00510 |
| Contact | Joel Kent |
| Correspondent | Joel Kent 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 | 2021-04-19 |
| Decision Date | 2021-10-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682104302 | K211171 | 000 |
| 00840682104135 | K211171 | 000 |