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, Laser, Scanning
510(k) Number K112880
Device Name CLEARPATH DS-120(R) LENS FLUORESCENCE BIOMICROSCOPE
Applicant
Freedom Meditech, Inc.
10455 Pacific Center Ct.
San Diego,  CA  92121
Applicant Contact CRAIG H MISRACH
Correspondent
Freedom Meditech, Inc.
10455 Pacific Center Ct.
San Diego,  CA  92121
Correspondent Contact CRAIG H MISRACH
Regulation Number886.1570
Classification Product Code
MYC  
Date Received09/30/2011
Decision Date 01/31/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Clinical Trials NCT01425346
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-