K931282 is an FDA 510(k) clearance for the VOLUME TRANSDUCER. This device is classified as a Cystometer, Electrical Recording (Class II - Special Controls, product code EXQ).
Submitted by Life-Tech Intl., Inc. (Houston, US). The FDA issued a Cleared decision on September 17, 1993, 189 days after receiving the submission on March 12, 1993.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1620.
| 510(k) Number | K931282 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 12, 1993 |
| Decision Date | September 17, 1993 |
| Days to Decision | 189 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | EXQ — Cystometer, Electrical Recording |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1620 |