NEOPAP SYSTEM


Device Classification Name

ventilator, non-continuous (respirator)

510(k) Number K103410
Device Name NEOPAP SYSTEM
Applicant
CHILDRENS MEDICAL VENTURES LLC
suite 200, 3919 william
penn highway
murrysville, 
PA 
15668

Applicant Contact scott wright
Correspondent
CHILDRENS MEDICAL VENTURES LLC
suite 200, 3919 william
penn highway
murrysville, 
PA 
15668

Correspodent Contact scott wright
Regulation Number 868.5905
Classification Product Code
BZD  
Date Received 11/22/2010
Decision Date 03/30/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No