CENTRA VIEW DEVICE LINK SYSTEM

Device Classification Name

monitor,physiological,patient(without arrhythmia detection or alarms)

510(k) Number K033283
Device Name CENTRA VIEW DEVICE LINK SYSTEM
Applicant
ICU DATASYSTEMS, INC.
2153 se hawthorne road
suite 220
gainesville, 
FL 
32641

Applicant Contact samuel w coons
Regulation Number 870.2300
Classification Product Code
MWI  
Date Received 10/14/2003
Decision Date 10/27/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No