The following data is part of a premarket notification filed by Fertile Time, Ltd. with the FDA for Fertility Forecaster Computer Program.
| Device ID | K880618 |
| 510k Number | K880618 |
| Device Name: | FERTILITY FORECASTER COMPUTER PROGRAM |
| Classification | Device, Fertility Diagnostic, Proceptive |
| Applicant | FERTILE TIME, LTD. 92 STONE HURST LN. Dix Hills, NY 11746 |
| Contact | Susan Nudelman |
| Correspondent | Susan Nudelman FERTILE TIME, LTD. 92 STONE HURST LN. Dix Hills, NY 11746 |
| 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 | 1988-02-16 |
| Decision Date | 1988-06-24 |