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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
510(k) Number K181923
Device Name Quantum Workstation 12.1
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 Number870.4330
Classification Product Code
DRY  
Date Received07/18/2018
Decision Date 08/17/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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