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 Grid, Amsler
510(k) Number K863429
Device Name MODIFIED DEVICE FOR SELF EXAMINATION OF EYES
Applicant
Wheel Checkers
2020 S. Bannock St.
Denver ,  CO  80223
Applicant Contact GIESKIENG
Correspondent
Wheel Checkers
2020 S. Bannock St.
Denver ,  CO  80223
Correspondent Contact GIESKIENG
Regulation Number886.1330
Classification Product Code
HOQ  
Date Received09/04/1986
Decision Date 01/20/1987
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
-
-