VIANOX DELIVERY SYSTEM, MODEL I


Device Classification Name

analyzer, nitric oxide

510(k) Number K023014
Device Name VIANOX DELIVERY SYSTEM, MODEL I
Original Applicant
PULMONOX MEDICAL, INC.
10835-120th st.
suite 200
edmonton, ab, 

CA

t5h 3p9

Original Contact paula tomat
Regulation Number 868.2380
Classification Product Code
MRP  
Subsequent Product Codes
MRN   MRQ  
Date Received 09/10/2002
Decision Date 08/14/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No