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FDA 510(k) Application Details - K110525
Device Classification Name
Recorder, Magnetic Tape, Medical
More FDA Info for this Device
510(K) Number
K110525
Device Name
Recorder, Magnetic Tape, Medical
Applicant
VITALOGRAPH(IRELAND) LTD.
ENNIS INDUSTRIAL ESTATE
GORT ROAD BUSINESS PARK
ENNIS, CO. CLARE EI IE
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Contact
TOM J HEALY
Other 510(k) Applications for this Contact
Regulation Number
870.2800
More FDA Info for this Regulation Number
Classification Product Code
DSH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/23/2011
Decision Date
11/23/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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