VISENSIA, VISENSIA WITH ALERT


Device Classification Name

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

510(k) Number K110953
Device Name VISENSIA, VISENSIA WITH ALERT
Applicant
OBS MEDICAL
rosemary house 31
church green stanford
in the vale oxford, 

GB

sn7 8hu

Applicant Contact chris weatherall
Correspondent
OBS MEDICAL
rosemary house 31
church green stanford
in the vale oxford, 

GB

sn7 8hu

Correspodent Contact chris weatherall
Regulation Number 870.1025
Classification Product Code
MHX  
Date Received 04/05/2011
Decision Date 06/15/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No