K812178 is an FDA 510(k) clearance for the LIFE-TECH #'S 1106/1156 UROLABS. This device is classified as a Cystometric Gas (carbon-dioxide) On Hydraulic Device (Class II - Special Controls, product code FAP).
Submitted by Life-Tech Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 13, 1981, 10 days after receiving the submission on August 3, 1981.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1620.
| 510(k) Number | K812178 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 03, 1981 |
| Decision Date | August 13, 1981 |
| Days to Decision | 10 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 |