FDA 510(k) Application Details - K962783

Device Classification Name Plethysmograph, Impedance

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510(K) Number K962783
Device Name Plethysmograph, Impedance
Applicant BIOANALOGICS, INC.
18140 SMOKESIGNAL DR.
SAN DIEGO, CA 92127 US
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Contact CAROL L PATTERSON
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Regulation Number 870.2770

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Classification Product Code DSB
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Date Received 07/17/1996
Decision Date 10/23/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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