The following data is part of a premarket notification filed by Datex-ohmeda, Inc. with the FDA for Datex-ohmeda Cardiocap 5, F-mx, F-mxg And Accessories.
| Device ID | K992323 |
| 510k Number | K992323 |
| Device Name: | DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIES |
| Classification | Monitor, St Segment With Alarm |
| Applicant | DATEX-OHMEDA, INC. 3 HIGHWOOD DR. Tewksbury, MA 01876 |
| Contact | Joel C Kent |
| Correspondent | Joel C Kent DATEX-OHMEDA, INC. 3 HIGHWOOD DR. Tewksbury, MA 01876 |
| Product Code | MLD |
| Subsequent Product Code | BZG |
| Subsequent Product Code | BZQ |
| Subsequent Product Code | CBQ |
| Subsequent Product Code | CBR |
| Subsequent Product Code | CBS |
| Subsequent Product Code | CCI |
| Subsequent Product Code | CCK |
| Subsequent Product Code | CCL |
| Subsequent Product Code | DPS |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DSA |
| Subsequent Product Code | DSK |
| Subsequent Product Code | DXN |
| Subsequent Product Code | FIL |
| Subsequent Product Code | KOI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-12 |
| Decision Date | 1999-11-01 |