The following data is part of a premarket notification filed by Verimed Holdings, Inc. with the FDA for Electro-myographic Perineometer.
| Device ID | K854193 |
| 510k Number | K854193 |
| Device Name: | ELECTRO-MYOGRAPHIC PERINEOMETER |
| Classification | Perineometer |
| Applicant | VERIMED HOLDINGS, INC. 2888 NE 25TH. COURT Fort Lauderdale, FL 33305 |
| Contact | William Hassel |
| Correspondent | William Hassel VERIMED HOLDINGS, INC. 2888 NE 25TH. COURT Fort Lauderdale, FL 33305 |
| Product Code | HIR |
| CFR Regulation Number | 884.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-15 |
| Decision Date | 1986-06-09 |