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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 K221203
Device Name AHI System
Applicant
Fifth Eye Inc.
110 Miller Avenue, Suite 300
Ann Arbor,  MI  48104
Applicant Contact Jennifer Baird
Correspondent
Biologics Consulting
1555 King Street, Suite 300
Alexandria,  VA  22314
Correspondent Contact Donna-Bea Tillman
Regulation Number870.2220
Classification Product Code
QNV  
Subsequent Product Code
QNL  
Date Received04/26/2022
Decision Date 07/14/2022
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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