The following data is part of a premarket notification filed by Tonometrics, Inc. with the FDA for Tonomitor (tm) + Sump.
| Device ID | K883234 |
| 510k Number | K883234 |
| Device Name: | TONOMITOR (TM) + SUMP |
| Classification | Electrode, Ph, Stomach |
| Applicant | TONOMETRICS, INC. 4903 SANGAMORE RD. Bethesda, MD 20816 |
| Contact | Donald L Mackeen |
| Correspondent | Donald L 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 | 1988-08-01 |
| Decision Date | 1988-10-12 |