The following data is part of a premarket notification filed by Verimed Holdings, Inc. with the FDA for Verimed Perineometer.
| Device ID | K913912 |
| 510k Number | K913912 |
| Device Name: | VERIMED PERINEOMETER |
| Classification | Perineometer |
| Applicant | VERIMED HOLDINGS, INC. 1401 E. BROWARD BLVD. SUITE 200 Fort Lauderdale, FL 33301 |
| Contact | Douglas Mee |
| Correspondent | Douglas Mee VERIMED HOLDINGS, INC. 1401 E. BROWARD BLVD. SUITE 200 Fort Lauderdale, FL 33301 |
| Product Code | HIR |
| CFR Regulation Number | 884.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-29 |
| Decision Date | 1992-06-16 |