PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVER


Device Classification Name

transducer, pressure, catheter tip

510(k) Number K080813
Device Name PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVER
Applicant
RADI MEDICAL SYSTEMS AB
palmbladsgatan 10
uppsala, 

SE

s-754 50

Applicant Contact bjorn palmgren
Correspondent
RADI MEDICAL SYSTEMS AB
palmbladsgatan 10
uppsala, 

SE

s-754 50

Correspodent Contact bjorn palmgren
Regulation Number 870.2870
Classification Product Code
DXO  
Subsequent Product Code
DQX  
Date Received 03/21/2008
Decision Date 07/01/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No