MERCURY VCO2 MODULE WITH CAPNOSTAT 5


Device Classification Name

spirometer, monitoring (w/wo alarm)

510(k) Number K080652
Device Name MERCURY VCO2 MODULE WITH CAPNOSTAT 5
Applicant
RESPIRONICS NOVAMETRIX LLC
5 technology drive
wallingford, 
CT 
06492

Applicant Contact kevin mader
Correspondent
RESPIRONICS NOVAMETRIX LLC
5 technology drive
wallingford, 
CT 
06492

Correspodent Contact kevin mader
Regulation Number 868.1850
Classification Product Code
BZK  
Date Received 03/07/2008
Decision Date 06/20/2008
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