FACEFIT AND FACEFIT PORTED NON-INVASIVE VENTILATION MASKS


Device Classification Name

ventilator, non-continuous (respirator)

510(k) Number K121747
Device Name FACEFIT AND FACEFIT PORTED NON-INVASIVE VENTILATION MASKS
Applicant
INTERSURGICAL INCORPORATED
417 electronics parkway
liverpool, 
NY 
13088

Applicant Contact michael zalewski
Correspondent
INTERSURGICAL INCORPORATED
417 electronics parkway
liverpool, 
NY 
13088

Correspodent Contact michael zalewski
Regulation Number 868.5905
Classification Product Code
BZD  
Date Received 06/14/2012
Decision Date 03/14/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Category: Uncategorized