ISA CO2, ISA AX+, ISA OR+


Device Classification Name

analyzer, gas, carbon-dioxide, gaseous-phase

510(k) Number K103604
Device Name ISA CO2, ISA AX+, ISA OR+
Applicant
PHASEIN AB
4213 winnequah dr.
madison, 
WI 
53716

Applicant Contact david weissburg
Correspondent
PHASEIN AB
4213 winnequah dr.
madison, 
WI 
53716

Correspodent Contact david weissburg
Regulation Number 868.1400
Classification Product Code
CCK  
Date Received 12/09/2010
Decision Date 04/06/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No