The following data is part of a premarket notification filed by Exercise Your Eyes, Inc. with the FDA for Eyeport Vision Training System.
Device ID | K051684 |
510k Number | K051684 |
Device Name: | EYEPORT VISION TRAINING SYSTEM |
Classification | Fixation, Vision Training, Binocular |
Applicant | EXERCISE YOUR EYES, INC. 133 KA DRIVE Kula, HI 96790 |
Contact | Jacob Liberman |
Correspondent | Jacob Liberman EXERCISE YOUR EYES, INC. 133 KA DRIVE Kula, HI 96790 |
Product Code | NXR |
CFR Regulation Number | 886.1290 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-06-23 |
Decision Date | 2006-03-17 |
Summary: | summary |