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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 Street
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
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