The following data is part of a premarket notification filed by Datex-ohmeda, Inc. with the FDA for Trip Tonometry Catheter, 8f.
| Device ID | K992181 |
| 510k Number | K992181 |
| Device Name: | TRIP TONOMETRY CATHETER, 8F |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | DATEX-OHMEDA, INC. 3 HIGHWOOD DR. Tewksbury, MA 01876 |
| Contact | Joel Kent |
| Correspondent | Joel Kent DATEX-OHMEDA, INC. 3 HIGHWOOD DR. Tewksbury, MA 01876 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-28 |
| Decision Date | 1999-08-24 |