TELEMEDCARE HEALTH MONITOR


Device Classification Name

transmitters and receivers, physiological signal, radiofrequency

510(k) Number K103796
Device Name TELEMEDCARE HEALTH MONITOR
Applicant
TELEMEDCARE PTY LTD
unit 7, 6-8 crewe place
rosebery, new south wales, 

AU

2018

Applicant Contact steven m moody
Correspondent
TELEMEDCARE PTY LTD
unit 7, 6-8 crewe place
rosebery, new south wales, 

AU

2018

Correspodent Contact steven m moody
Regulation Number 870.2910
Classification Product Code
DRG  
Date Received 12/27/2010
Decision Date 08/03/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No