FDA 510(k) Application Details - K981720

Device Classification Name Plethysmograph, Impedance

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510(K) Number K981720
Device Name Plethysmograph, Impedance
Applicant RENAISSANCE TECHNOLOGY, INC.
170 PHEASANT RUN
NEWTOWN, PA 18940 US
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Contact PHILIP E HAMSKI
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Regulation Number 870.2770

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Classification Product Code DSB
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Date Received 05/05/1998
Decision Date 02/08/1999
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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