The following data is part of a premarket notification filed by Vismed, Inc. with the FDA for Tks 4000 Auto Perimeter.
Device ID | K873122 |
510k Number | K873122 |
Device Name: | TKS 4000 AUTO PERIMETER |
Classification | Perimeter, Automatic, Ac-powered |
Applicant | VISMED, INC. 7920 SILVERTON SUITE I San Diego, CA 92126 |
Contact | Dale A Rorabaugh |
Correspondent | Dale A Rorabaugh VISMED, INC. 7920 SILVERTON SUITE I San Diego, CA 92126 |
Product Code | HPT |
CFR Regulation Number | 886.1605 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-08-10 |
Decision Date | 1987-11-02 |