PRESSURIZED INFUSION PUMP


Device Classification Name

system, gastrointestinal motility (electrical)

510(k) Number K122294
Device Name PRESSURIZED INFUSION PUMP
Applicant
MUI SCIENTIFIC
145 traders blvd. east, # 34
mississauga, 

CA

l4z 3l3

Applicant Contact tammy mui
Correspondent
MUI SCIENTIFIC
145 traders blvd. east, # 34
mississauga, 

CA

l4z 3l3

Correspodent Contact tammy mui
Regulation Number 876.1725
Classification Product Code
FFX  
Date Received 07/31/2012
Decision Date 11/01/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No