The following data is part of a premarket notification filed by Seeing Machines Limited with the FDA for Truefield Analyzer.
Device ID | K063310 |
510k Number | K063310 |
Device Name: | TRUEFIELD ANALYZER |
Classification | Perimeter, Automatic, Ac-powered |
Applicant | SEEING MACHINES LIMITED 11440 WEST BERNARDO CT. SUITE 300 San Diego, CA 92127 -1644 |
Contact | Alan Donald |
Correspondent | Alan Donald SEEING MACHINES LIMITED 11440 WEST BERNARDO CT. SUITE 300 San Diego, CA 92127 -1644 |
Product Code | HPT |
CFR Regulation Number | 886.1605 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-11-02 |
Decision Date | 2007-08-02 |
Summary: | summary |