The following data is part of a premarket notification filed by Oculab, Inc. with the FDA for Bio-pen Calculator.
| Device ID | K860205 |
| 510k Number | K860205 |
| Device Name: | BIO-PEN CALCULATOR |
| Classification | Medical Computers And Software For Ophthalmic Use |
| Applicant | OCULAB, INC. 443 WEST COLORADO ST. Gendale, CA 91204 |
| Contact | Richard W Teasdale |
| Correspondent | Richard W Teasdale OCULAB, INC. 443 WEST COLORADO ST. Gendale, CA 91204 |
| Product Code | LQB |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-22 |
| Decision Date | 1986-04-24 |