The following data is part of a premarket notification filed by Datex-engstrom, Inc. with the FDA for Trip Tonometry Catheter, 18f.
| Device ID | K980384 |
| 510k Number | K980384 |
| Device Name: | TRIP TONOMETRY CATHETER, 18F |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| 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 | CCK |
| Subsequent Product Code | CBR |
| Subsequent Product Code | KNT |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-02 |
| Decision Date | 1998-05-01 |