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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name gas control unit, cardiopulmonary bypass
510(k) Number K202733
Device Name Quantum Ventilation Module
Applicant
Spectrum Medical Ltd
Harrier 4, Meteor Business Park, Cheltenham Road East
Gloucester,  GB GL2 9QL
Applicant Contact Colleen Powell
Correspondent
Spectrum Medical Ltd
Harrier 4, Meteor Business Park, Cheltenham Road East
Gloucester,  GB GL2 9QL
Correspondent Contact Colleen Powell
Regulation Number870.4300
Classification Product Code
DTX  
Date Received09/18/2020
Decision Date 10/16/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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