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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
510(k) Number K130957
Device Name WVSM (WIRLESS VITAL SIGNS MONITOR)
Applicant
ATHENA GTX
3620 SW61ST STREET
SUITE 395
DES MOINES,  IA  50321
Applicant Contact SEAN MAHONEY
Correspondent
ATHENA GTX
3620 SW61ST STREET
SUITE 395
DES MOINES,  IA  50321
Correspondent Contact SEAN MAHONEY
Regulation Number870.2300
Classification Product Code
MWI  
Subsequent Product Codes
DQA   DRG   DXN  
Date Received04/05/2013
Decision Date 04/30/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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