The following data is part of a premarket notification filed by Stereo Optical Co., Inc. with the FDA for Optec 1000 Dmv Vision Tester Modify.
Device ID | K875237 |
510k Number | K875237 |
Device Name: | OPTEC 1000 DMV VISION TESTER MODIFY |
Classification | Chart, Visual Acuity |
Applicant | STEREO OPTICAL CO., INC. 3539 NORTH KENTON Chicago, IL 60641 |
Contact | Joseph Andera |
Correspondent | Joseph Andera STEREO OPTICAL CO., INC. 3539 NORTH KENTON Chicago, IL 60641 |
Product Code | HOX |
CFR Regulation Number | 886.1150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-12-22 |
Decision Date | 1988-03-17 |