SPEACELABS MULTIGAS MODULE


Device Classification Name

analyzer, gas, nitrous-oxide, gaseous phase (anesthetic conc.)

510(k) Number K112173
Device Name SPEACELABS MULTIGAS MODULE
Applicant
SPACELABS HEALTHCARE
p.o. box 3018
nederland, 
CO 
80466

Applicant Contact thomas kroenke
Correspondent
SPACELABS HEALTHCARE
p.o. box 3018
nederland, 
CO 
80466

Correspodent Contact thomas kroenke
Regulation Number 868.1700
Classification Product Code
CBR  
Subsequent Product Codes
CBQ   CBS   CCK   CCL   NHO  
NHP   NHQ  
Date Received 07/28/2011
Decision Date 10/05/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls