The following data is part of a premarket notification filed by Micromedical Technologies, Inc. with the FDA for Computer Eye Tracking Sys./eng Exam. Chair & Table.
Device ID | K863424 |
510k Number | K863424 |
Device Name: | COMPUTER EYE TRACKING SYS./ENG EXAM. CHAIR & TABLE |
Classification | Nystagmograph |
Applicant | MICROMEDICAL TECHNOLOGIES, INC. RR BOX 176-1 RTES 4 AND 104 Auburn, IL 62615 |
Contact | Richard D Miles,phd |
Correspondent | Richard D Miles,phd MICROMEDICAL TECHNOLOGIES, INC. RR BOX 176-1 RTES 4 AND 104 Auburn, IL 62615 |
Product Code | GWN |
CFR Regulation Number | 882.1460 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-09-04 |
Decision Date | 1987-03-23 |