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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 K181942
Device Name Quantum Ventilation Module
Applicant
Spectrum Medical Ltd
Harrier 4, Meteor Business Park, Cheltenham Road East
gloucester,  GB gl2 9ql
Applicant Contact mark drain
Correspondent
Spectrum Medical Ltd
Harrier 4, Meteor Business Park, Cheltenham Road East
gloucester,  GB gl2 9ql
Correspondent Contact mark drain
Regulation Number870.4300
Classification Product Code
DTX  
Date Received07/20/2018
Decision Date 10/18/2018
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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