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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sleeve, Limb, Compressible
510(k) Number K222823
Device Name AeroDVx Arm System
Applicant
Sun Scientific, Inc.
145 Palisade St.
Suite Ll11
Dobbs Ferry,  NY  10522
Applicant Contact Allan Alward
Correspondent
Sun Scientific, Inc.
145 Palisade St.
Suite Ll11
Dobbs Ferry,  NY  10522
Correspondent Contact Allan Alward
Regulation Number870.5800
Classification Product Code
JOW  
Date Received09/19/2022
Decision Date 09/07/2023
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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