SIDESTREAM NEBULIZER


Device Classification Name

nebulizer (direct patient interface)

510(k) Number K991725
Device Name SIDESTREAM NEBULIZER
Applicant
INSPIRED MEDICAL PRODUCTS LTD.
6329 w. waterview ct.
mccordsville, 
IN 
46055 -9501

Applicant Contact paul e dryden
Correspondent
INSPIRED MEDICAL PRODUCTS LTD.
6329 w. waterview ct.
mccordsville, 
IN 
46055 -9501

Correspodent Contact paul e dryden
Regulation Number 868.5630
Classification Product Code
CAF  
Date Received 05/20/1999
Decision Date 07/30/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No