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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name transmitters and receivers, physiological signal, radiofrequency
510(k) Number K111922
Device Name VOCARE MYHEALTH TABLET
Applicant
VOCARE, INC
5225 EXPLORATION DRIVE
indianapolis,  IN  46241
Applicant Contact steve peabody
Correspondent
VOCARE, INC
5225 EXPLORATION DRIVE
indianapolis,  IN  46241
Correspondent Contact steve peabody
Regulation Number870.2910
Classification Product Code
DRG  
Date Received07/06/2011
Decision Date 12/02/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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