The following data is part of a premarket notification filed by Oculab, Inc. with the FDA for Pach-pen Calculator.
| Device ID | K884619 |
| 510k Number | K884619 |
| Device Name: | PACH-PEN CALCULATOR |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | OCULAB, INC. 443 WEST COLORADO ST. Gendale, CA 91204 |
| Contact | David A Wallace |
| Correspondent | David A Wallace OCULAB, INC. 443 WEST COLORADO ST. Gendale, CA 91204 |
| Product Code | DXG |
| CFR Regulation Number | 870.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-04 |
| Decision Date | 1989-02-02 |