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 K854047
Device Name IN-HOME VISION MONITORING KIT
Applicant
Rich-Larky Company, Inc.
1029 Vermont Ave. #400
Washington,  DC  20005
Applicant Contact EUGENE M PFEIFER
Correspondent
Rich-Larky Company, Inc.
1029 Vermont Ave. #400
Washington,  DC  20005
Correspondent Contact EUGENE M PFEIFER
Regulation Number886.1150
Classification Product Code
HOX  
Date Received10/03/1985
Decision Date 12/13/1985
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
-
-