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 Ophthalmoscope, Ac-Powered
510(k) Number K992606
Device Name CANON LASER BLOOD FLOWMETER (CLBF) MODEL 100
Applicant
Canon USA, Inc.
One Canon Plz.
Lake Success,  NY  11042
Applicant Contact KEN SHADOFF
Correspondent
Canon USA, Inc.
One Canon Plz.
Lake Success,  NY  11042
Correspondent Contact KEN SHADOFF
Regulation Number886.1570
Classification Product Code
HLI  
Date Received08/03/1999
Decision Date 06/21/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-