The following data is part of a premarket notification filed by Apimeds, Inc with the FDA for Extt-101.
| Device ID | K082436 |
| 510k Number | K082436 |
| Device Name: | EXTT-101 |
| Classification | Perineometer |
| Applicant | APIMEDS, INC 5401 S. COTTONWOOD CT Greenwood Village, CO 80121 |
| Contact | Kevin Walls |
| Correspondent | Kevin Walls APIMEDS, INC 5401 S. COTTONWOOD CT Greenwood Village, CO 80121 |
| Product Code | HIR |
| CFR Regulation Number | 884.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-25 |
| Decision Date | 2009-05-29 |