The following data is part of a premarket notification filed by Bioself, Inc. with the FDA for Bioself 2000 Fertility Indicator.
| Device ID | K904211 |
| 510k Number | K904211 |
| Device Name: | BIOSELF 2000 FERTILITY INDICATOR |
| Classification | Device, Fertility Diagnostic, Proceptive |
| Applicant | BIOSELF, INC. 7, AVENUE DE THONEX CASE POSTALE 172-CH-1226 Thonex-geneve-suisse, CH |
| Contact | James Pulcrano |
| Correspondent | James Pulcrano BIOSELF, INC. 7, AVENUE DE THONEX CASE POSTALE 172-CH-1226 Thonex-geneve-suisse, CH |
| 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 | 1990-09-12 |
| Decision Date | 1992-10-14 |