The following data is part of a premarket notification filed by Tonometrics, Inc. with the FDA for Trip Cic Catheter.
| Device ID | K920849 |
| 510k Number | K920849 |
| Device Name: | TRIP CIC CATHETER |
| Classification | Electrode, Ph, Stomach |
| Applicant | TONOMETRICS, INC. 4903 SANGAMORE RD. Bethesda, MD 20816 |
| Contact | Donald Mackeen |
| Correspondent | Donald Mackeen TONOMETRICS, INC. 4903 SANGAMORE RD. Bethesda, MD 20816 |
| Product Code | FFT |
| CFR Regulation Number | 876.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-25 |
| Decision Date | 1995-03-17 |