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FDA 510(k) Application Details - K172196
Device Classification Name
Plethysmograph, Impedance
More FDA Info for this Device
510(K) Number
K172196
Device Name
Plethysmograph, Impedance
Applicant
ECOM Medical, Inc
27127 Calle Arroyo, Suite 1905
San Juan Capistrano, CA 92675 US
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Contact
Guy Lowery
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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
07/21/2017
Decision Date
09/19/2017
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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