K812177 is an FDA 510(k) clearance for the LIFE-TECH #1857 PRESSURE/POLOT MODULE. This device is classified as a Cystometer, Electrical Recording (Class II - Special Controls, product code EXQ).
Submitted by Life-Tech Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 9, 1981, 37 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 | K812177 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 03, 1981 |
| Decision Date | September 09, 1981 |
| Days to Decision | 37 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | EXQ — Cystometer, Electrical Recording |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1620 |