AEROCHAMBER PLUS FLOW-VU ANTI-STATIC VALVED HOLDING CHAMBER (VHC)


Device Classification Name

holding chambers, direct patient interface

510(k) Number K112010
Device Name AEROCHAMBER PLUS FLOW-VU ANTI-STATIC VALVED HOLDING CHAMBER (VHC)
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
NVP  
Date Received 07/14/2011
Decision Date 07/11/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

Type Traditional
Reviewed by Third Party No

Combination Product

No