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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Contact ANGELA HALWAS
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Regulation Number 870.2800

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Classification Product Code DSH
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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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