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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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More FDA Info for this Product Code
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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