NEB-90 LARGE VOLUME MEDICATION NEBULIZER


Device Classification Name

nebulizer (direct patient interface)

510(k) Number K080657
Device Name NEB-90 LARGE VOLUME MEDICATION NEBULIZER
Applicant
MEDI NUCLEAR CORP., INC.
4610 littlejohn st.
baldwin park, 
CA 
91706

Applicant Contact michael mcpeck
Correspondent
MEDI NUCLEAR CORP., INC.
4610 littlejohn st.
baldwin park, 
CA 
91706

Correspodent Contact michael mcpeck
Regulation Number 868.5630
Classification Product Code
CAF  
Date Received 03/07/2008
Decision Date 06/30/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No