The following data is part of a premarket notification filed by E.b.s., Inc. with the FDA for Bioma 2000.
| Device ID | K862808 |
| 510k Number | K862808 |
| Device Name: | BIOMA 2000 |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | E.B.S., INC. 660 ROCHON ST-LAURENT (QUEBEC) Canada, CA H4l 1t4 |
| Contact | Sylvain Boucher |
| Correspondent | Sylvain Boucher E.B.S., INC. 660 ROCHON ST-LAURENT (QUEBEC) Canada, CA H4l 1t4 |
| Product Code | DXG |
| CFR Regulation Number | 870.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-23 |
| Decision Date | 1987-02-19 |