FDA 510(k) Applications for Medical Device:
Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K972962 3M COMPANY 1311 VALENCIA AVE.
TUSTIN CA 92680
K973472 3M HEALTH CARE 1311 VALENCIA AVE.
TUSTIN CA 92780
K980732 3M HEALTH CARE 1311 VALENCIA AVE.
TUSTIN CA 92780
K001388 DIDECO 49 PLAIN ST.
NORTH ATTLEBORO MA 02760-4153
K955379 INTERNATIONAL BIOPHYSICS CORP. 4020 SOUTH INDUSTRIAL DR.
AUSTIN TX 78744
K955380 INTERNATIONAL BIOPHYSICS CORP. 4020 SOUTH INDUSTRIAL DR.
AUSTIN TX 78744
K202154 LivaNova Deutschland GmbH Lindberghstr. 25
Munich 80939
K090147 MAQUET CARDIOPULMONARY AG HECHINGER STRASSE 38
HIRRLINGEN 72145
K012743 MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR.
MINNEAPOLIS MN 55038
K133157 MEDTRONIC, INC. 7611 NORTHLAND DRIVE
MINNEAPOLIS MN 55428
K103168 SORIN GROUP DEUTSCHLAND GMBH 49 PLAIN STREET
NORTH ATTLEBORO MA 02760
K071725 SPECTRUM MEDICAL LTD HARRIER 4,METEOR BUSINESS PARK
GLOUCESTER, GLOUCESTERHSIRE GL2 9QL
K072131 SPECTRUM MEDICAL LTD HARRIER 4,METEOR BUSINESS PARK
GLOUCESTER, GLOUCESTERHSIRE GL2 9QL
K091908 SPECTRUM MEDICAL LTD HARRIER 4,METEOR BUSINESS PARK
GLOUCESTER, GLOUCESTERHSIRE GL2 9QL
K173591 Spectrum Medical Ltd Harrier 4, Meteor Business Park, Cheltenham Road East
Gloucester GL2 9QL
K163657 Spectrum Medical Ltd Harrier 4, Meteor Business Park, Cheltenham Road East
Gloucester GL2 9QL
K202557 Spectrum Medical Ltd Harrier 4, Meteor Business Park, Cheltenham Road East
Gloucester GL2 9QL
K181923 Spectrum Medical Ltd Harrier 4, Meteor Business Park, Cheltenham Road East
Gloucester GL2 9QL
K110957 SPECTRUM MEDICAL, LLP CHELTENHAM ROAD EAST
GLOUCESTER GL2 9QL
K062468 SPECTRUM MEDICAL, LLP 27 BATH ROAD
CHELTENHAM GL53 7TH
K123039 TERUMO CARDIOVASCULAR SYSTEMS CORP. 6200 JACKSON RD.
ANN ARBOR MI 48103
K133658 TERUMO CARDIOVASCULAR SYSTEMS CORP. 6200 JACKSON RD.
ANN ARBOR MI 48103
K182110 Terumo Cardiovascular Systems Corporation 6200 Jackson Road
Ann Arbor MI 48103




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