The following data is part of a premarket notification filed by Datex-ohmeda with the FDA for Datex-ohmeda Compact Airway Module M-caiovx And M-covx (version 01) And Accessories.
| Device ID | K001814 |
| 510k Number | K001814 |
| Device Name: | DATEX-OHMEDA COMPACT AIRWAY MODULE M-CAIOVX AND M-COVX (VERSION 01) AND ACCESSORIES |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | DATEX-OHMEDA THREE HIGHWOOD DR. Tewksbury, MA 01876 |
| Contact | Joel Kent |
| Correspondent | Joel Kent DATEX-OHMEDA THREE HIGHWOOD DR. Tewksbury, MA 01876 |
| 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 |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-15 |
| Decision Date | 2000-08-23 |