The following data is part of a premarket notification filed by Mentor O & O, Inc. with the FDA for Mentor Potential Acuity Meter.
Device ID | K821932 |
510k Number | K821932 |
Device Name: | MENTOR POTENTIAL ACUITY METER |
Classification | Chart, Visual Acuity |
Applicant | MENTOR O & O, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HOX |
CFR Regulation Number | 886.1150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-06-29 |
Decision Date | 1982-08-03 |