MOBILECARE MONITOR


Device Classification Name

transmitters and receivers, physiological signal, radiofrequency

510(k) Number K122333
Device Name MOBILECARE MONITOR
Applicant
AFRAME DIGITAL, INC.
1889 preston white dr ste 101
reston, 
VA 
20191

Applicant Contact jill thorpe
Correspondent
AFRAME DIGITAL, INC.
1889 preston white dr ste 101
reston, 
VA 
20191

Correspodent Contact jill thorpe
Regulation Number 870.2910
Classification Product Code
DRG  
Date Received 08/02/2012
Decision Date 11/19/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No