VITALSENS, AINGEAL, V-POD


Device Classification Name

monitor, physiological, patient(with arrhythmia detection or alarms)

510(k) Number K110015
Device Name VITALSENS, AINGEAL, V-POD
Applicant
INTELESENS LIMITED
24301 woodsage drive
bonita springs, 
FL 
34134

Applicant Contact paul dryden
Correspondent
INTELESENS LIMITED
24301 woodsage drive
bonita springs, 
FL 
34134

Correspodent Contact paul dryden
Regulation Number 870.1025
Classification Product Code
MHX  
Date Received 01/03/2011
Decision Date 05/20/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No