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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter
510(k) Number K160582
Device Name WiCap
Applicant
Athena Gtx
5900 NW 86th St.
Suite 300
Johnson,  IA  50131
Applicant Contact Sean Mahoney
Correspondent
Athena Gtx
5900 NW 86th St.
Suite 300
Johnson,  IA  50131
Correspondent Contact Sean Mahoney
Regulation Number870.2700
Classification Product Code
DQA  
Subsequent Product Code
CCK  
Date Received03/01/2016
Decision Date 09/02/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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