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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 K183349
Device Name AeroDVx System
Applicant
Sun Scientific, Inc.
145 Palisade St.
Dobbs Ferry,  NY  10522
Applicant Contact Allan Alward
Correspondent
Sun Scientific, Inc.
145 Palisade St.
Dobbs Ferry,  NY  10522
Correspondent Contact Allan Alward
Regulation Number870.5800
Classification Product Code
JOW  
Date Received12/03/2018
Decision Date 07/19/2019
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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