TWINGUARD WITH CAPNOGRAPH ACCESSORY


Device Classification Name

analyzer, gas, carbon-dioxide, gaseous-phase

510(k) Number K080527
Device Name TWINGUARD WITH CAPNOGRAPH ACCESSORY
Applicant
TRAWAX PTY LIMITED
29662 avante
laguna niguel, 
CA 
92677

Applicant Contact cindy martin
Correspondent
TRAWAX PTY LIMITED
29662 avante
laguna niguel, 
CA 
92677

Correspodent Contact cindy martin
Regulation Number 868.1400
Classification Product Code
CCK  
Subsequent Product Code
MNK  
Date Received 02/26/2008
Decision Date 10/31/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No