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 pump, infusion
510(k) Number K994375
Device Name HORIZON LIGHT
Applicant
B. BRAUN MEDICAL, INC.
1601 WALLACE DR., SUITE 150
CARROLLTON,  TX  75006
Applicant Contact GARY GULYAS
Correspondent
B. BRAUN MEDICAL, INC.
1601 WALLACE DR., SUITE 150
CARROLLTON,  TX  75006
Correspondent Contact GARY GULYAS
Regulation Number880.5725
Classification Product Code
FRN  
Date Received12/27/1999
Decision Date 03/08/2000
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
Recalls CDRH Recalls
-
-