K890466 is an FDA 510(k) clearance for the SIGMOID TONOMITOR. This device is classified as a Catheter, Rectal (Class II - Special Controls, product code GBT).
Submitted by Tonometrics, Inc. (Bethesda, US). The FDA issued a Cleared decision on April 21, 1989, 80 days after receiving the submission on January 31, 1989.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K890466 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 31, 1989 |
| Decision Date | April 21, 1989 |
| Days to Decision | 80 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | GBT — Catheter, Rectal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5980 |