BABI*PLUS PRESSURE RELIEF MANIFOLD – 10CM H20, 12.5CM H20, 15CM H20


Device Classification Name

ventilator, non-continuous (respirator)

510(k) Number K110383
Device Name BABI*PLUS PRESSURE RELIEF MANIFOLD – 10CM H20, 12.5CM H20, 15CM H20
Applicant
A PLUS MEDICAL
5431 avenida encinas
suite g
carlsbad, 
CA 
92008

Applicant Contact thomas c loescher
Correspondent
A PLUS MEDICAL
5431 avenida encinas
suite g
carlsbad, 
CA 
92008

Correspodent Contact thomas c loescher
Regulation Number 868.5905
Classification Product Code
BZD  
Date Received 02/10/2011
Decision Date 08/01/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No