K900494 is an FDA 510(k) clearance for the SYNECTICS LIBERTY SYSTEM, PC POLYGRAF & POLYGRAM. This device is classified as a Cystometric Gas (carbon-dioxide) On Hydraulic Device (Class II - Special Controls, product code FAP).
Submitted by Synectics-Dantec (Irving, US). The FDA issued a Cleared decision on June 11, 1990, 129 days after receiving the submission on February 2, 1990.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1620.
| 510(k) Number | K900494 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 02, 1990 |
| Decision Date | June 11, 1990 |
| Days to Decision | 129 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FAP — Cystometric Gas (carbon-dioxide) On Hydraulic Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1620 |