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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 K091908
Device Name M3 MONITOR
Applicant
SPECTRUM MEDICAL LTD
HARRIER 4,METEOR BUSINESS PARK
CHELTENHAM ROAD EAST
gloucester, gloucesterhsire,  GB gl2 9ql
Applicant Contact steve turner
Correspondent
UNDERWRITERS LABORATORIES, INC.
12 LABORATORY DR.
research triangle,  NC  27709
Correspondent Contact jeff d rongero
Regulation Number870.4330
Classification Product Code
DRY  
Subsequent Product Code
KRL  
Date Received06/25/2009
Decision Date 07/10/2009
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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