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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Controller, Temperature, Cardiopulmonary Bypass
510(k) Number K212657
Device Name Quantum Heater-Cooler
Applicant
Spectrum Medical , Ltd.
Harrier 4, Meteor Business Park, Cheltenham Rd. E.
Gloucester,  GB GL29QL
Applicant Contact Colleen Powell
Correspondent
Spectrum Medical , Ltd.
Harrier 4, Meteor Business Park, Cheltenham Rd. E.
Gloucester,  GB GL29QL
Correspondent Contact Colleen Powell
Regulation Number870.4250
Classification Product Code
DWC  
Date Received08/23/2021
Decision Date 05/06/2022
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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