K932149 is an FDA 510(k) clearance for the THOUGHT TECHNOLOGY VAGINAL & RECTAL ELECTRODE. This device is classified as a Perineometer (Class II - Special Controls, product code HIR).
Submitted by Thought Technology , Ltd. (Montreal, Quebec, CA). The FDA issued a Cleared decision on May 11, 1995, 737 days after receiving the submission on May 4, 1993.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 884.1425.
| 510(k) Number | K932149 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 04, 1993 |
| Decision Date | May 11, 1995 |
| Days to Decision | 737 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | HIR — Perineometer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1425 |