The following data is part of a premarket notification filed by Datex-engstrom, Inc. with the FDA for Cs/3(tm) Monitors*.
| Device ID | K974792 |
| 510k Number | K974792 |
| Device Name: | CS/3(TM) MONITORS* |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | DATEX-ENGSTROM, INC. 2 HIGHWOOD DR. Tewksbury, MA 01876 |
| Contact | Joel Kent |
| Correspondent | Joel Kent DATEX-ENGSTROM, INC. 2 HIGHWOOD DR. Tewksbury, MA 01876 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-22 |
| Decision Date | 1998-06-02 |