The following data is part of a premarket notification filed by Datex-engstrom, Inc. with the FDA for Trip Tonometry Catheter, 16f.
| Device ID | K983366 |
| 510k Number | K983366 |
| Device Name: | TRIP TONOMETRY CATHETER, 16F |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | DATEX-ENGSTROM, INC. 3 HIGHWOOD DR. Tewksbury, MA 01876 |
| Contact | Joel Kent |
| Correspondent | Joel Kent DATEX-ENGSTROM, INC. 3 HIGHWOOD DR. Tewksbury, MA 01876 |
| Product Code | KNT |
| Subsequent Product Code | CBR |
| Subsequent Product Code | CCK |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-24 |
| Decision Date | 1998-12-23 |