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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 K173591
Device Name Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas
Applicant
Spectrum Medical , Ltd.
Harrier 4, Meteor Business Park, Cheltenham Rd. E.
Gloucester,  GB GL29QL
Applicant Contact Mark Drain
Correspondent
Spectrum Medical , Ltd.
Harrier 4, Meteor Business Park, Cheltenham Rd. E.
Gloucester,  GB GL29QL
Correspondent Contact Mark Drain
Regulation Number870.4330
Classification Product Code
DRY  
Date Received11/21/2017
Decision Date 03/28/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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