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 K121198
Device Name BW685, BW685S
Applicant
BIEGLER GMBH
24301 WOODSAGE DR
BONITA SPRINGS,  FL  34134
Applicant Contact PAUL DRYDEN
Correspondent
BIEGLER GMBH
24301 WOODSAGE DR
BONITA SPRINGS,  FL  34134
Correspondent Contact PAUL DRYDEN
Regulation Number880.5725
Classification Product Code
LGZ  
Date Received04/19/2012
Decision Date 07/12/2012
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
-
-