The following data is part of a premarket notification filed by American Endoscopy, Inc. with the FDA for Proxima 1 Ph Monitor.
| Device ID | K841384 |
| 510k Number | K841384 |
| Device Name: | PROXIMA 1 PH MONITOR |
| Classification | Electrode, Ph, Stomach |
| Applicant | AMERICAN ENDOSCOPY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FFT |
| CFR Regulation Number | 876.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-03-20 |
| Decision Date | 1984-07-19 |