K926218 is an FDA 510(k) clearance for the EISMAN-TRIES MEP (MULTIPLE ELECTRODE PROBE), a Perineometer (Class II — Special Controls, product code HIR), submitted by Sandhill Scientific, Inc. (Littleton, US). The FDA issued a Cleared decision on August 26, 1994, 624 days after receiving the submission on December 10, 1992. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 884.1425.
| 510(k) Number | K926218 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 10, 1992 |
| Decision Date | August 26, 1994 |
| Days to Decision | 624 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | HIR — Perineometer |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.1425 |