FDA 510(k) Application Details - K960925

Device Classification Name Recorder, Magnetic Tape, Medical

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510(K) Number K960925
Device Name Recorder, Magnetic Tape, Medical
Applicant NORTHEAST MONITORING, INC.
730 BOSTON POST RD., SUITE 22
SUDBURY, MA 01776 US
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Contact MARK HUBELBANK
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Regulation Number 870.2800

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Classification Product Code DSH
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Date Received 03/06/1996
Decision Date 07/31/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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