The following data is part of a premarket notification filed by Vistech Consultants, Inc. with the FDA for Vistech Vcts 6000.
Device ID | K840255 |
510k Number | K840255 |
Device Name: | VISTECH VCTS 6000 |
Classification | Chart, Visual Acuity |
Applicant | VISTECH CONSULTANTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | HOX |
CFR Regulation Number | 886.1150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-01-23 |
Decision Date | 1984-04-13 |