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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, electrocardiograph, telephone
510(k) Number K133703
Device Name PHYSIOGLOVE ET SYSTEM
Applicant
COMMWELL R&D LTD.
555 THIRTEENTH STREET NW
washington,  DC  20004
Applicant Contact jonathon kahan
Correspondent
COMMWELL R&D LTD.
555 THIRTEENTH STREET NW
washington,  DC  20004
Correspondent Contact jonathon kahan
Regulation Number870.2920
Classification Product Code
DXH  
Subsequent Product Code
DPS  
Date Received12/03/2013
Decision Date 08/18/2014
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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