EXPRESSION INFORMATION PORTAL


Device Classification Name

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

510(k) Number K121424
Device Name EXPRESSION INFORMATION PORTAL
Applicant
INVIVO CORPORATION
12151 research pkwy
orlando, 
FL 
32826

Applicant Contact rusty kelly
Correspondent
INVIVO CORPORATION
12151 research pkwy
orlando, 
FL 
32826

Correspodent Contact rusty kelly
Regulation Number 870.2300
Classification Product Code
MWI  
Date Received 05/14/2012
Decision Date 06/13/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls