GALEMED NEB-EASY NEBULIZER


Device Classification Name

nebulizer (direct patient interface)

510(k) Number K021742
Device Name GALEMED NEB-EASY NEBULIZER
Original Applicant
GALEMED CORP.
29201 via norte
temecula, 
CA 
92591

Original Contact tom shanks
Regulation Number 868.5630
Classification Product Code
CAF  
Date Received 05/28/2002
Decision Date 10/25/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No