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 |