The following data is part of a premarket notification filed by Kowa Optimed, Inc. with the FDA for Automatic Perimeter, Ap-340.
| Device ID | K881219 |
| 510k Number | K881219 |
| Device Name: | AUTOMATIC PERIMETER, AP-340 |
| Classification | Perimeter, Automatic, Ac-powered |
| Applicant | KOWA OPTIMED, INC. 20001 SOUTH VERMONT AVE. Torrance, CA 90502 |
| Contact | Mike Yamashita |
| Correspondent | Mike Yamashita KOWA OPTIMED, INC. 20001 SOUTH VERMONT AVE. Torrance, CA 90502 |
| Product Code | HPT |
| CFR Regulation Number | 886.1605 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-22 |
| Decision Date | 1988-05-03 |