The following data is part of a premarket notification filed by Bionexus, Inc. with the FDA for Femtest.
| Device ID | K844173 |
| 510k Number | K844173 |
| Device Name: | FEMTEST |
| Classification | Insufflator, Carbon-dioxide, Uterotubal (and Accessories) |
| Applicant | BIONEXUS, INC. 5257 N. BLVD. P.O. DRAWER 58517 Raleigh, NC 27658 |
| Contact | Charles R Desmet |
| Correspondent | Charles R Desmet BIONEXUS, INC. 5257 N. BLVD. P.O. DRAWER 58517 Raleigh, NC 27658 |
| Product Code | HES |
| CFR Regulation Number | 884.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-25 |
| Decision Date | 1985-08-14 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() FEMTEST 74518789 not registered Dead/Abandoned |
Chefaro International B.V. 1994-04-29 |
![]() FEMTEST 73554842 1417980 Dead/Cancelled |
CHEFARO INTERNATIONAL B.V. 1985-08-22 |
![]() FEMTEST 73488913 1330764 Dead/Cancelled |
BioNexus, Inc. 1984-07-09 |