The following data is part of a premarket notification filed by Tonometrics, Inc. with the FDA for Sigmoid Tonomitor.
| Device ID | K890466 |
| 510k Number | K890466 |
| Device Name: | SIGMOID TONOMITOR |
| Classification | Catheter, Rectal |
| Applicant | TONOMETRICS, INC. 4903 SANGAMORE RD. Bethesda, MD 20816 |
| Contact | L Mackeen,phd |
| Correspondent | L Mackeen,phd TONOMETRICS, INC. 4903 SANGAMORE RD. Bethesda, MD 20816 |
| Product Code | GBT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-31 |
| Decision Date | 1989-04-21 |