K931179 is an FDA 510(k) clearance for the UROLAB SPECTRUM, a Cystometric Gas (carbon-dioxide) On Hydraulic Device (Class II — Special Controls, product code FAP), submitted by Life-Tech Intl., Inc. (Houston, US). The FDA issued a Cleared decision on November 18, 1993, 254 days after receiving the submission on March 9, 1993. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1620.
| 510(k) Number | K931179 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 09, 1993 |
| Decision Date | November 18, 1993 |
| Days to Decision | 254 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FAP — Cystometric Gas (carbon-dioxide) On Hydraulic Device |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1620 |