The following data is part of a premarket notification filed by Datex-engstrom, Inc. with the FDA for Mri Compatible Monitor And Accessories.
| Device ID | K980362 |
| 510k Number | K980362 |
| Device Name: | MRI COMPATIBLE MONITOR AND ACCESSORIES |
| Classification | Electrocardiograph |
| Applicant | DATEX-ENGSTROM, INC. 2 HIGHWOOD DR. Tewksbury, MA 01876 |
| Contact | Joel C Kent |
| Correspondent | Joel C Kent DATEX-ENGSTROM, INC. 2 HIGHWOOD DR. Tewksbury, MA 01876 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-29 |
| Decision Date | 1998-06-30 |