The following data is part of a premarket notification filed by Biosearch Medical Products, Inc. with the FDA for Perineometer & Vaginal Probe (biofeedback Monitor #20 And Vaginal Probe).
| Device ID | K970145 |
| 510k Number | K970145 |
| Device Name: | PERINEOMETER & VAGINAL PROBE (BIOFEEDBACK MONITOR #20 AND VAGINAL PROBE) |
| Classification | Perineometer |
| Applicant | BIOSEARCH MEDICAL PRODUCTS, INC. 35 INDUSTRIAL PKWY. P.O. BOX 1700 Somerville, NJ 08876 |
| Contact | Martin Dyck |
| Correspondent | Martin Dyck BIOSEARCH MEDICAL PRODUCTS, INC. 35 INDUSTRIAL PKWY. P.O. BOX 1700 Somerville, NJ 08876 |
| Product Code | HIR |
| CFR Regulation Number | 884.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-15 |
| Decision Date | 1997-08-11 |
| Summary: | summary |