The following data is part of a premarket notification filed by Optimed, Inc. with the FDA for Optimed Advantage.
| Device ID | K883458 |
| 510k Number | K883458 |
| Device Name: | OPTIMED ADVANTAGE |
| Classification | Perimeter, Automatic, Ac-powered |
| Applicant | OPTIMED, INC. 100 HEGENBERGER RD. SUITE 210 Oakland, CA 94621 |
| Contact | Douglas J Donaldson |
| Correspondent | Douglas J Donaldson OPTIMED, INC. 100 HEGENBERGER RD. SUITE 210 Oakland, CA 94621 |
| Product Code | HPT |
| CFR Regulation Number | 886.1605 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-12 |
| Decision Date | 1988-11-07 |