AEROECLIPSE DURABLE BREATH ACTUATED NEBULIZER


Device Classification Name

nebulizer (direct patient interface)

510(k) Number K080926
Device Name AEROECLIPSE DURABLE BREATH ACTUATED NEBULIZER
Applicant
TRUDELL MEDICAL INTL.
725 third st.
london, ontario, 

CA

n5v 5g4

Applicant Contact darryl fischer
Correspondent
TRUDELL MEDICAL INTL.
725 third st.
london, ontario, 

CA

n5v 5g4

Correspodent Contact darryl fischer
Regulation Number 868.5630
Classification Product Code
CAF  
Date Received 04/02/2008
Decision Date 08/12/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No