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


New Search Back To Search Results
Device Classification Name transducer, blood-pressure, extravascular
510(k) Number K112203
Model CGP001, CTHR001/CPAR001, CART001, CEPD001, CCMP001
Device Name COMPASS GLOBAL PRESSURE, COMPASS THORACENTESIS, PARACENTESIS, COMPARTMENT PRESSURE, EPIDURAL ASSIST, ARTERIAL ASSIST
Original Applicant
MIRADOR BIOMEDICAL, INC.
2815 wastlake avenue
suite 220
seattle,  WA  98102
Original Contact justin hulvershorn
Regulation Number870.2850
Classification Product Code
DRS  
Subsequent Product Code
DXG  
Date Received08/01/2011
Decision Date 12/14/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-