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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Facility Use
510(k) Number K202970
Device Name Ventway Sparrow
Applicant
Inovytech Medical Solutions , Ltd.
3 Hanagar St.
Hod Hasharon Tel-Aviv,  IL 4501306
Applicant Contact Dana Hofeller
Correspondent
C/O Promedic, LLC
131 Bay Point Dr. NE
St Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number868.5895
Classification Product Code
CBK  
Date Received09/30/2020
Decision Date 01/29/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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