AEROTRACH PLUS VALVED HOLDING CHAMBER (VHC)


definition

Device Classification Name

nebulizer (direct patient interface)

510(k) Number K001137
Device Name AEROTRACH PLUS VALVED HOLDING CHAMBER (VHC)
Original Applicant
TRUDELL MEDICAL INT’L
725 third st.
london, ontario, 

CA

n5v 5g4

Original Contact tom holbrook
Regulation Number 868.5630
Classification Product Code
CAF  
Date Received 04/10/2000
Decision Date 07/05/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

Type Special
Reviewed by Third Party No

Combination Product

No