The following data is part of a premarket notification filed by Titmus Optical, Inc. with the FDA for Miller/nadler Glare Tester.
Device ID | K832762 |
510k Number | K832762 |
Device Name: | MILLER/NADLER GLARE TESTER |
Classification | Photostimulator, Ac-powered |
Applicant | TITMUS OPTICAL, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | HLX |
CFR Regulation Number | 886.1630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-08-16 |
Decision Date | 1983-09-29 |