DISPOSABLE GAS SAMPLING LINE WITH AND WITHOUT IN-LINE FILTER


Device Classification Name

analyzer, gas, carbon-dioxide, gaseous-phase

510(k) Number K122075
Device Name DISPOSABLE GAS SAMPLING LINE WITH AND WITHOUT IN-LINE FILTER
Applicant
INTERSURGICAL, INC.
417 electronics pkwy.
liverpool, 
NY 
13088

Applicant Contact michael zaleewski
Correspondent
INTERSURGICAL, INC.
417 electronics pkwy.
liverpool, 
NY 
13088

Correspodent Contact michael zaleewski
Regulation Number 868.1400
Classification Product Code
CCK  
Date Received 07/16/2012
Decision Date 12/20/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No