MANOMETER


Device Classification Name

monitor, airway pressure (includes gauge and/or alarm)

510(k) Number K122077
Device Name MANOMETER
Applicant
INTERSURGICAL, INC.
417 electronics pkwy.
liverpool, 
NY 
13088

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

Correspodent Contact michael zalewski
Regulation Number 868.2600
Classification Product Code
CAP  
Date Received 07/16/2012
Decision Date 01/10/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No