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 Unit, Neonatal Phototherapy
510(k) Number K120820
Device Name GIRAFFE BLUE SPOT PT LITE
Applicant
Lumitex, Inc.
8443 Dow Cir.
Strongsville,  OH  44136
Applicant Contact DAVID FELTY
Correspondent
Lumitex, Inc.
8443 Dow Cir.
Strongsville,  OH  44136
Correspondent Contact DAVID FELTY
Regulation Number880.5700
Classification Product Code
LBI  
Date Received03/19/2012
Decision Date 06/08/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-