PRESSURE WIRE SENSOR, MODELS 12003/12303, 12004/12304


Device Classification Name

transducer, pressure, catheter tip

510(k) Number K022187
Device Name PRESSURE WIRE SENSOR, MODELS 12003/12303, 12004/12304
Original Applicant
RADI MEDICAL SYSTEMS AB
palmbladsgatan 10
uppsala, 

SE

s-754 50

Original Contact mats granlund
Regulation Number 870.2870
Classification Product Code
DXO  
Subsequent Product Code
KRB  
Date Received 07/05/2002
Decision Date 09/24/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No