FDA 510(k) Application Details - K140102

Device Classification Name Plethysmograph, Impedance

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510(K) Number K140102
Device Name Plethysmograph, Impedance
Applicant VASOCOM, INC.
2014 FORD RD., UNIT G
BRISTOL, PA 19007 US
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Contact JAMES GUNNERSON
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Regulation Number 870.2770

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Classification Product Code DSB
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Date Received 01/15/2014
Decision Date 02/12/2014
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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