RADIANALYZER, MODEL 12710


definition

Device Classification Name

computer, blood-pressure

510(k) Number K002067
Device Name RADIANALYZER, MODEL 12710
Original Applicant
RADI MEDICAL SYSTEMS AB
palmbladsgatan 10
uppsala, 

SE

s-754 50

Original Contact mats granlund
Regulation Number 870.1110
Classification Product Code
DSK  
Date Received 07/07/2000
Decision Date 01/11/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Traditional
Reviewed by Third Party No

Combination Product

No