FDA 510(k) Application Details - K083093

Device Classification Name Plethysmograph, Impedance

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510(K) Number K083093
Device Name Plethysmograph, Impedance
Applicant CHEETAH MEDICAL INC.
12154 DARNESTOWN RD. #236
GAITHERSBURG, MD 20878 US
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Contact Rhona Shanker
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Regulation Number 870.2770

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Classification Product Code DSB
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Date Received 10/17/2008
Decision Date 12/15/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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