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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name system, gastrointestinal motility (electrical)
510(K) Number K120997
Device Name BAROSTAT SOFTWARE OPTION
Applicant
CROSPON, LTD.
24301 woodsage drive
bonita springs,  FL  34134
Contact paul dryden
Regulation Number876.1725
Classification Product Code
FFX  
Date Received04/02/2012
Decision Date 08/27/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-