The following data is part of a premarket notification filed by Datex-ohmeda with the FDA for Cs/3 Critical Care Monitor With S-icu99(a).
| Device ID | K000168 |
| 510k Number | K000168 |
| Device Name: | CS/3 CRITICAL CARE MONITOR WITH S-ICU99(A) |
| 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 | 2000-01-20 |
| Decision Date | 2000-04-13 |