EASYSTAT PH, PCO2, PO2, HCT, NA+, K+, CA++ ANALYZER


Device Classification Name

electrode measurement, blood-gases (pco2, po2) and blood ph

510(k) Number K021515
Device Name EASYSTAT PH, PCO2, PO2, HCT, NA+, K+, CA++ ANALYZER
Original Applicant
MEDICA CORP.
14 deangelo dr.
bedford, 
MA 
01730

Original Contact dean honkonen
Regulation Number 862.1120
Classification Product Code
CHL  
Subsequent Product Codes
CEM   GKF   JFP   JGS  
Date Received 05/10/2002
Decision Date 07/16/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No