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 K882634
Device Name VISUAL CONTRAST SENSITI., POTENTIAL ACUITY&GLARE
Applicant
Vistech Consultants, Inc.
1372 Noth Fairfield Rd.
Dayton,  OH  45432
Applicant Contact DENNIS J MCCREIGHT
Correspondent
Vistech Consultants, Inc.
1372 Noth Fairfield Rd.
Dayton,  OH  45432
Correspondent Contact DENNIS J MCCREIGHT
Regulation Number886.1150
Classification Product Code
HOX  
Date Received06/27/1988
Decision Date 07/15/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-