Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name chart, visual acuity
510(k) Number K853481
Device Name VISTECH VCTS GLARE TESTER
Applicant
VISTECH CONSULTANTS, INC.
1372 NOTH FAIRFIELD RD.
DAYTON,  OH  45432
Applicant Contact KEN BLARVELT
Correspondent
VISTECH CONSULTANTS, INC.
1372 NOTH FAIRFIELD RD.
DAYTON,  OH  45432
Correspondent Contact KEN BLARVELT
Regulation Number886.1150
Classification Product Code
HOX  
Date Received08/20/1985
Decision Date 10/29/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-