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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
510(k) Number K200567
Device Name ASI Plethysmogrpah Analyzer
Applicant
Arterial Stiffness, Inc.
1000 Westgate Dr., Suite 101b
Saint Paul,  MN  55114
Applicant Contact Jospeh Henry Shaw
Correspondent
Arterial Stiffness, Inc.
1000 Westgate Dr., Suite 101b
Saint Paul,  MN  55114
Correspondent Contact Nida Shoubash
Regulation Number870.2780
Classification Product Code
JOM  
Date Received03/04/2020
Decision Date 02/26/2021
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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