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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 K122763
Device Name PHYSIOLOGICAL DATA PROCESSOR
Applicant
ZEPHYR TECHNOLOGY CORPORATION
1151 HOPE STREET
STAMFORD,  CT  06907
Applicant Contact RICHARD KEEN
Correspondent
ZEPHYR TECHNOLOGY CORPORATION
1151 HOPE STREET
STAMFORD,  CT  06907
Correspondent Contact RICHARD KEEN
Regulation Number870.2910
Classification Product Code
DRG  
Date Received09/10/2012
Decision Date 06/20/2013
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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