FDA 510(k) Application Details - K082967

Device Classification Name Electrocardiograph

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510(K) Number K082967
Device Name Electrocardiograph
Applicant MEDICAL POSITIONING, INC.
21521 HUMMINGBIRD STREET
TRABUCO CANYON, CA 92679 US
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Contact CAROL WHITE
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Regulation Number 870.2340

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Classification Product Code DPS
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Date Received 10/06/2008
Decision Date 03/26/2009
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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