The following data is part of a premarket notification filed by Datex-engstrom, Inc. with the FDA for Cs/3 Compact Airway Module, M-covx.
| Device ID | K982091 |
| 510k Number | K982091 |
| Device Name: | CS/3 COMPACT AIRWAY MODULE, M-COVX |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | DATEX-ENGSTROM, INC. 3 HIGHWOOD DR. Tewksbury, MA 01876 |
| Contact | Joel C Kent |
| Correspondent | Joel C Kent DATEX-ENGSTROM, INC. 3 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 | 1998-06-15 |
| Decision Date | 1998-12-22 |