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FDA 510(k) Application Details - K022297
Device Classification Name
Recorder, Magnetic Tape, Medical
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510(K) Number
K022297
Device Name
Recorder, Magnetic Tape, Medical
Applicant
CARDIOCOMM SOLUTIONS, INC.
3060 CEDAR HILL RD., SUITE 201
VICTORIA, B.C. V8T 3J5 CA
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ANGELA HALWAS
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Regulation Number
870.2800
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Classification Product Code
DSH
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More FDA Info for this Product Code
Date Received
07/16/2002
Decision Date
09/27/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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