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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adjunctive Hemodynamic Indicator With Decision Point
510(k) Number K212219
Device Name AHI System
Applicant
Fifth Eye, Inc.
110 Miller Ave., Suite 300
Ann Arbor,  MI  48104
Applicant Contact Jennifer A. Baird
Correspondent
Biologics Consulting Group
1555 King St.,
Suite 300
Alexandria,  VA  22314
Correspondent Contact Donna-Bea Tillman
Regulation Number870.2220
Classification Product Code
QNV  
Subsequent Product Code
QNL  
Date Received07/16/2021
Decision Date 12/03/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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