K970145 is an FDA 510(k) clearance for the PERINEOMETER & VAGINAL PROBE (BIOFEEDBACK MONITOR #20 AND VAGINAL PROBE), a Perineometer (Class II — Special Controls, product code HIR), submitted by Biosearch Medical Products, Inc. (Somerville, US). The FDA issued a Cleared decision on August 11, 1997, 208 days after receiving the submission on January 15, 1997. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 884.1425.
| 510(k) Number | K970145 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 15, 1997 |
| Decision Date | August 11, 1997 |
| Days to Decision | 208 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 |