The following data is part of a premarket notification filed by Ovusoft, Llc. with the FDA for Tcoyf Fertility Software Version 1.0.
| Device ID | K002726 |
| 510k Number | K002726 |
| Device Name: | TCOYF FERTILITY SOFTWARE VERSION 1.0 |
| Classification | Device, Fertility Diagnostic, Proceptive |
| Applicant | OVUSOFT, LLC. 402 DUNHAM MASSIE DR. Hampton, VA 23669 -1744 |
| Contact | Gene Grant |
| Correspondent | Gene Grant OVUSOFT, LLC. 402 DUNHAM MASSIE DR. Hampton, VA 23669 -1744 |
| Product Code | LHD |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-31 |
| Decision Date | 2001-04-06 |