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 Warmer, Thermal, Infusion Fluid
510(k) Number K091336
Device Name IVNOW MODULAR FLUID WARMER, 120V, MODEL IVNOW-1, IVNOW-2, IVNOW-3, IVNOW-6, IVNOW MODULAR FLUID WARMER 230V
Applicant
Enthermics Medical Systems, Inc.
1601 K St. NW
Washington,  DC  20006
Applicant Contact EMALEE G MURPHY
Correspondent
Enthermics Medical Systems, Inc.
1601 K St. NW
Washington,  DC  20006
Correspondent Contact EMALEE G MURPHY
Regulation Number880.5725
Classification Product Code
LGZ  
Date Received05/06/2009
Decision Date 05/07/2010
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
-
-