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 K120168
Device Name LULLABY LED PHOTTHERAPY SYSTEM
Applicant
WIPRO GE HEALTHCARE PRIVATE, LTD.
8880 GORMAN ROAD
LAUREL,  MD  20723
Applicant Contact AGATA ANTHONY
Correspondent
WIPRO GE HEALTHCARE PRIVATE, LTD.
8880 GORMAN ROAD
LAUREL,  MD  20723
Correspondent Contact AGATA ANTHONY
Regulation Number880.5700
Classification Product Code
LBI  
Date Received01/19/2012
Decision Date 05/02/2012
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
-
-