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FDA 510(k) Application Details - K082242
Device Classification Name
Plethysmograph, Impedance
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510(K) Number
K082242
Device Name
Plethysmograph, Impedance
Applicant
OSYPKA MEDICAL, INC.
7855 IVANHOE AVE., SUITE 226
LA JOLLA, CA 92037 US
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MARKUS OSYPKA
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Regulation Number
870.2770
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Classification Product Code
DSB
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Date Received
08/07/2008
Decision Date
10/08/2008
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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