The following data is part of a premarket notification filed by Datex-engstrom, Inc. with the FDA for Datex-engstrom Network.
| Device ID | K974101 |
| 510k Number | K974101 |
| Device Name: | DATEX-ENGSTROM NETWORK |
| Classification | System, Network And Communication, Physiological Monitors |
| 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 | MSX |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-30 |
| Decision Date | 1998-02-06 |