The following data is part of a premarket notification filed by Nishitomo Co., Inc. with the FDA for L Sophia.
| Device ID | K901512 |
| 510k Number | K901512 |
| Device Name: | L SOPHIA |
| Classification | Device, Fertility Diagnostic, Proceptive |
| Applicant | NISHITOMO CO., INC. 449-3, HIRUDA, TAMAKI-CHO WATARAI-GUN, MIE-PREF. Japan, JP 519-0423 |
| Contact | Nishimura |
| Correspondent | Nishimura NISHITOMO CO., INC. 449-3, HIRUDA, TAMAKI-CHO WATARAI-GUN, MIE-PREF. Japan, JP 519-0423 |
| 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 | 1990-03-29 |
| Decision Date | 1990-07-20 |