COMPASS GLOBAL PRESSURE, COMPASS THORACENTESIS, PARACENTESIS, COMPARTMENT PRESSURE, EPIDURAL ASSIST, ARTERIAL ASSIST


Device Classification Name

transducer, blood-pressure, extravascular

510(k) Number K112203
Device Name COMPASS GLOBAL PRESSURE, COMPASS THORACENTESIS, PARACENTESIS, COMPARTMENT PRESSURE, EPIDURAL ASSIST, ARTERIAL ASSIST
Applicant
MIRADOR BIOMEDICAL, INC.
2815 wastlake avenue
suite 220
seattle, 
WA 
98102

Applicant Contact justin hulvershorn
Correspondent
MIRADOR BIOMEDICAL, INC.
2815 wastlake avenue
suite 220
seattle, 
WA 
98102

Correspodent Contact justin hulvershorn
Regulation Number 870.2850
Classification Product Code
DRS  
Subsequent Product Code
DXG  
Date Received 08/01/2011
Decision Date 12/14/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No