The following data is part of a premarket notification filed by Instrumentarium Corp. with the FDA for Trip Ngs & Sigmoid Catheter Phi Slide Calculator.
| Device ID | K955018 |
| 510k Number | K955018 |
| Device Name: | TRIP NGS & SIGMOID CATHETER PHI SLIDE CALCULATOR |
| Classification | Electrode, Ph, Stomach |
| Applicant | INSTRUMENTARIUM CORP. ONE FINANCIAL CENTER Boston, MA 02111 |
| Contact | Carolyn S Langer |
| Correspondent | Carolyn S Langer INSTRUMENTARIUM CORP. ONE FINANCIAL CENTER Boston, MA 02111 |
| Product Code | FFT |
| CFR Regulation Number | 876.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-02 |
| Decision Date | 1996-01-30 |