The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Datex-ohmeda S/5 Compact Airway Module (model Family E-caiovx) E-caiovx, E-caiov, E-caio, E-covx, E-cov, E-co & Accesacc.
| Device ID | K051092 |
| 510k Number | K051092 |
| Device Name: | DATEX-OHMEDA S/5 COMPACT AIRWAY MODULE (MODEL FAMILY E-CAIOVX) E-CAIOVX, E-CAIOV, E-CAIO, E-COVX, E-COV, E-CO & ACCESACC |
| Classification | Analyzer, Gas, Oxygen, Gaseous-phase |
| Applicant | GE HEALTHCARE 86 PILGRIM ROAD Needham, MA 02492 |
| Contact | Joel C Kent |
| Correspondent | Joel C Kent GE HEALTHCARE 86 PILGRIM ROAD Needham, MA 02492 |
| Product Code | CCL |
| 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 | NHO |
| Subsequent Product Code | NHP |
| Subsequent Product Code | NHQ |
| CFR Regulation Number | 868.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-28 |
| Decision Date | 2005-05-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682103671 | K051092 | 000 |
| 20840682102814 | K051092 | 000 |
| 20840682102876 | K051092 | 000 |
| 20840682102920 | K051092 | 000 |
| 20840682103668 | K051092 | 000 |
| 00840682103886 | K051092 | 000 |
| 20840682102852 | K051092 | 000 |
| 20840682102869 | K051092 | 000 |
| 20840682103613 | K051092 | 000 |
| 20840682103705 | K051092 | 000 |
| 20840682102845 | K051092 | 000 |
| 20840682103620 | K051092 | 000 |
| 20840682120672 | K051092 | 000 |
| 20840682120689 | K051092 | 000 |
| 20840682120658 | K051092 | 000 |
| 00840682103688 | K051092 | 000 |
| 00840682103596 | K051092 | 000 |
| 00840682103602 | K051092 | 000 |
| 00840682102803 | K051092 | 000 |