HEALTHLINE REDI-NEB MEDICATION NEBULIZER, MODEL RN-510


Device Classification Name

nebulizer (direct patient interface)

510(k) Number K080969
Device Name HEALTHLINE REDI-NEB MEDICATION NEBULIZER, MODEL RN-510
Applicant
MEDI NUCLEAR CORP., INC.
4610 littlejohn st.
baldwin park, 
CA 
91706

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

Correspodent Contact jerry schoen
Regulation Number 868.5630
Classification Product Code
CAF  
Date Received 04/04/2008
Decision Date 07/25/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No