The following data is part of a premarket notification filed by Datex-ohmeda with the FDA for Datex-ohmeda Cs/3 Telemetry System.
| Device ID | K000882 |
| 510k Number | K000882 |
| Device Name: | DATEX-OHMEDA CS/3 TELEMETRY SYSTEM |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| 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 | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-20 |
| Decision Date | 2000-06-05 |