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 |