• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name warmer, thermal, infusion fluid
510(k) Number K120860
Device Name INFU BOX TYPE 0412A
Original Applicant
MEDICAL RESCUE EQUIPMENT HOLDING AS
postboks 186
porsgrunn,  NO 3901
Original Contact knut fangberget
Classification Product Code
LGZ  
Date Received03/22/2012
Decision Date 05/08/2012
Decision substantially equivalent (SESE)
510k Review Panel General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-