FDA 510(k) Application Details - K032103

Device Classification Name Recorder, Magnetic Tape, Medical

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510(K) Number K032103
Device Name Recorder, Magnetic Tape, Medical
Applicant PHILIPS MEDICAL SYSTEMS
3000 MINUTEMAN RD.
ANDOVER, MA 01810 US
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Contact SONGHUA ZHANG
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Regulation Number 870.2800

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Classification Product Code DSH
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Date Received 07/08/2003
Decision Date 07/22/2003
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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