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 Biomicroscope, Slit-Lamp, Ac-Powered
510(k) Number K072861
Device Name CEEMAX SLIT LAMP (HALOGEN LAMP SERIES/SOLID STATE ILLUMINATION SERIES)
Applicant
Acheve Technology, Inc.
17100 Gillette Ave., Unit 113
Irvin,  CA  92614
Applicant Contact JIM-SON CHOU
Correspondent
Acheve Technology, Inc.
17100 Gillette Ave., Unit 113
Irvin,  CA  92614
Correspondent Contact JIM-SON CHOU
Regulation Number886.1850
Classification Product Code
HJO  
Date Received10/05/2007
Decision Date 06/24/2008
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
-
-