COMP A-I-R


Device Classification Name

nebulizer (direct patient interface)

510(k) Number K110860
Device Name COMP A-I-R
Applicant
OMRON HEALTHCARE, INC.
24301 woodsage drive
bonita springs, 
FL 
34134

Applicant Contact paul dryden
Correspondent
OMRON HEALTHCARE, INC.
24301 woodsage drive
bonita springs, 
FL 
34134

Correspodent Contact paul dryden
Regulation Number 868.5630
Classification Product Code
CAF  
Date Received 03/29/2011
Decision Date 09/02/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No